Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

Users Online : 44695

AbstractMaterial and MethodsResultsDiscussionConclusionReferencesDOI and Others
Article in PDF How to Cite Citation Manager Readers' Comments (0) Audio Visual Article Statistics Link to PUBMED Print this Article Send to a Friend
Advertisers Access Statistics Resources

Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : May | Volume : 16 | Issue : 5 | Page : UC09 - UC13 Full Version

Comparing Clonidine and Fentanyl as Adjuvants to Intrathecal Hyperbaric Ropivacaine in Elective Infraumbilical Surgeries- A Randomised Clinical Study


Published: May 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/56377.16341
Lakshmi Priya, BC Vijayalakshmi, HR Divya, Arjun Swaroop

1. Assistant Professor, Department of Anaesthesiology, Mysore Medical College and research Institute, Mysuru, Karnataka, India. 2. Professor, Department of Anaesthesiology, Mysore Medical College and research Institute, Mysuru, Karnataka, India. 3. Assistant Professor, Department of Ear, Nose and Throat, Mysore Medical College and research Institute, Mysuru, Karnataka, India. 4. Resident, Department of Anaesthesiology, Mysore Medical College and research Institute, Mysuru, Karnataka, India.

Correspondence Address :
Dr. Lakshmi Priya,
No. G02, Maple Block, Sankalp Central Park, Yadavagiri, Mysuru, Karnataka, India.
E-mail: c7drpriya@gmail.com

Abstract

Introduction: Ropivacaine is popular as a safe intrathecal anaesthetic drug due to its higher safety profile over bupivacaine. Intrathecal additives are known to increase the quality of anaesthesia and analgesic duration.

Aim: To compare the effects of clonidine and fentanyl as intrathecal adjuvants to hyperbaric ropivacaine in elective infraumbilical surgeries.

Materials and Methods: This randomized, double-blinded, clinical study was undertaken at Krishnarajendra hospital and Cheluvamba hospital, attached to Mysore Medical College and Research Institute, Mysuru, Karnataka, India, from January 2018 to June 2018. Total 60 adult patients aged between 18-60 years of age, American Society of Anesthesiologists (ASA) I and II status, and posted for infraumbilical surgeries, were randomized to two groups of 30 patients each i.e., group C patients receiving 2.5 mL of hyperbaric 0.42% ropivacaine and clonidine 15 mcg, and group F patients receiving 2.5 mL of hyperbaric 0.42% ropivacaine and fentanyl 25 mcg. The onset, extent and duration of sensory and motor blockade, heart rate, mean arterial pressure, prolongation of analgesia in the post operative period, and any complications were observed. Statistical analysis was done using student’s t-test, and Chi-square test to test significance of variables. The p-value <0.05 was taken as statistically significant.

Results: Demographic characteristics were comparable in both the groups. The onset of sensory blockade and the maximum height of sensory blockade attained were similar in both groups i.e., group C-2.12±0.22 min vs group F-2.24±0.66 min, group C-4.94±0.91 min vs group F-5.12±1.38 min, respectively. The duration of sensory blockade was prolonged in group C (148.5±10.84 min vs 109.37±14.5 min), resulting in delayed demand for analgesic after surgery in this group. The onset of motor block and the complete motor blockade was prolonged in group C patients (3.22±1.01 min vs 1.16±0.3 min, 6.8±1.49 min vs 3.72±1.31min). The recovery from motor blockade was also significantly delayed in Group C (125.17±13.29 min vs 95.47±13.08 min). The incidence of hypotension was similar in both the groups.

Conclusion: Clonidine, and fentanyl both provide early and adequate spinal anaesthesia, but the former (clonidine 15 mcg), prolongs the duration of spinal anaesthesia with Ropivacaine 0.42% hyperbaric solution, and significantly increases the time for the demand for analgesia in the recovery period, compared to fentanyl.

Keywords

Anesthetic adjuvants, Local anesthetics, Spinal anesthesia

Infraumbilical surgeries are commonly conducted under spinal anaesthesia. Ropivacaine, is a pure S-(-)-enantiomer, is a popular local anaesthetic of recent times due to its high safety profile over bupivacaine with reduced neurotoxicity and cardiac toxicity (1),(2). It has low lipid solubility and blocks nerve fibres involved in pain transmission to a greater degree than those involved in motor function (3),(4).

The plain solution available commercially exhibits variable and less predictable effects resulting in either insufficient block level inadequate for surgery or excessively high levels causing side effects and also has shorter duration of action (5).

Hyperbaric solutions made by the addition of dextrose to isobaric ropivacaine (6) had more predictable onset, with greater spread in the direction of gravity and less interpatient variability (7),(8) after spinal anaesthesia. It provides adequate intra operative anaesthesia and has a shorter duration of action (9), making it an ideal agent for day care surgeries. However, patients complain of pain in the early postoperative period, necessitating the use of systemic drugs like Non Steroidal Anti-inflammatory Drugs (NSAIDs) and opioids. Hence, it requires monitoring in the postoperative period.

Adjuvants such as clonidine and fentanyl, are added to intrathecal local anaesthetics to improve the quality of intraoperative anaesthesia and prolong the post operative analgesia. Clonidine, is a centrally acting partial α2 adrenergic agonist (220:1 α2 to α1) and provides dose dependent analgesia. Hypotension, bradycardia, sedation are some of its side-effects (10),(11). Fentanyl, a short-acting opioid, acts on μ1 and μ2 receptors. It facilitates reduction in dose of local anaesthetics and potentiates the afferent sensory blockade. Pruritis, urinary retention and respiratory depression are some of its side-effects (12),(13).

Literature search reveals many studies comparing different doses of clonidine and fentanyl as intrathecal adjuvants to isobaric ropivacaine (14),(15). Not many studies have been conducted on hyperbaric ropivacaine, since it is not commercially available. There are no studies with clonidine and fentanyl as intrathecal adjuvants to hyperbaric ropivacaine 0.42%.


Hence, this study was initiated to compare clonidine and fentanyl as additives to hyperbaric 0.42% ropivacaine for spinal anaesthesia. The primary objectives were to study the onset, duration of sensory blockade, maximum sensory blockade attained and time taken for the same, time taken for two segment regression, and regression of sensory block to S1, time of administration of rescue analgesia. Also, to study the onset of motor blockade, quality of motor blockade, time taken for the maximum motor blockade and duration of motor blockade. The secondary objectives were to study the haemodynamic changes such as hypotension, bradycardia and other side effects such as nausea, vomiting, shivering, pruritus and respiratory depression, if any.

Material and Methods

A randomized, double-blinded, clinical study was undertaken at Krishnarajendra hospital and Cheluvamba hospital, attached to Mysore Medical College and Research Institute, from January 2018 to June 2018. The Scientific Review Board and Ethics Board had approved the study (IEC REG:ECR/134/Inst/KA/2013). A total of 60 patients were enrolled.

Sample size calculation: The sample size was calculated based on the mean and standard deviation of complete sensory regression of spinal block after spinal anaesthesia On knee arthroscopy patients in a previous study(16). To achieve a difference of 30 min in the time for regression of spinal anaesthesia, with an expected effect size to standard deviation ratio of 0.9, and an acceptable alpha error of 0.05 and power of 80%, only 20 patients were required in each group. However, 30 patients were enrolled in each group to increase the power of the study and to compensate for any drop outs.

Inclusion criteria:

• Adult patients of either sex, aged between 18-60 years age.
• American Society of Anesthesiologists (ASA) I and II status
• Admitted for infraumbilical surgeries.

Exclusion criteria:

• Patients above ASA II status
• Chronic diseases such as diabetes and hypertension
• Known drug allergy
• Pregnant patients
• Patients with height less than 140 cm
• Body mass index ≥30 kg/m2.

Procedure

Patients were evaluated in the pre operative period for their fitness for surgery. They were explained about the study and their consent of participation was obtained in a pre-written format. They were randomized using shuffled sealed envelope method into two groups (Table/Fig 1):

• Group C: Received 2.5 mL of hyperbaric 0.42% ropivacaine (10.5 mg) with clonidine 15 mcg (0.1mL).
• Group F: Received 2.5 mL of hyperbaric 0.42% ropivacaine (10.5 mg) with fentanyl 25 mcg (0.5 mL).

Drug preparation of hyperbaric ropivacaine: Hyperbaric ropivacaine 0.42% was prepared by adding 0.5 mL of 50% dextrose to 2.5 mL of 0.5% isobaric ropivacaine. After addition of dextrose, the total volume 3 mL of the prepared drug contained 12.5 mg of ropivacaine and 250 mg of dextrose. Only 2.5 mL of the above preparation was taken and 0.1 mL of clonidine (15 mcg) or 0.5 mL of fentanyl (25 mcg) was added and given intrathecally. Thus, each millilitre of the study drug contained 4.2 mg of ropivacaine and 83.33 mg of dextrose. Sterile autoclaved ampoules of 50% dextrose were used. Samples of the prepared drug were tested in the laboratory for specific gravity and any possible bacterial contamination. The mean specific gravity of the sample drug was noted to be 1.0396 (specific gravity of CSF- 1.0004-1.00067). Culture sensitivity test was negative.

In the operation theatre, standard monitors were applied and the basal Heart Rate (HR), Mean Arterial Pressure (MAP), oxygen saturation (SpO2), Electrocardiogram (ECG) readings were obtained. Intravenous (IV) access was secured and patient was administered Ringer’s solution.

Lumbar puncture was performed by a junior anaesthetist with patient in the lateral recumbent posture in L2-L3/L3-L4 space with 25 G Quincke needle and the prepared study drug injected in intrathecal space under full asepsis. The patient was placed supine for the surgery, and the below study parameters were noted by the observer who was not aware of the composition of the drug. The patients were also unaware of the composition of the study drug. Monitoring of the HR, MAP, SpO2, and ECG were done every minute for the first 5 minutes post spinal anestheisa, thereafter every 5 minutes upto 30 minutes, and then every 10 minutes till the end of surgery, and for half hour after surgery. The patient and the observer were unaware of the composition of the study drug.

Parameters studied: The onset of sensory anaesthesia, maximum sensory level and the time taken for the same, onset of motor block, time for complete block, two segment sensory regression time, complete regression to S1, complete motor recovery was checked and recorded. Sensation was checked using pin prick with blunt needle. Modified Bromage scale was used for assessing the quality of motor blockade (Table/Fig 2) (17).

Visual Analogue Scale (VAS): In the postoperative period, analgesia was assessed using Visual Analogue Scale (VAS), wherein 0= no pain, and 10= severe pain.

Ramsay sedation scale: Sedation was assessed at 2,4,6,8,10,15,20, 25, 30, 45,60,75,90 min after injection of the study drug using the Ramsay sedation scale, wherein;

1: patient anxious, agitated or restless or both.
2: patient cooperative, oriented and tranquil.
3: patient responds to commands only.
4: patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
5: patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
6: patient exhibits no response.

Hypotension, defined as a fall in systolic blood pressure of >20% from the baseline or MAP <60 mmHg, was treated with Inj. mephenteramine 6 mg IV increments. Bradycardia, defined as HR<50 beats per minute, was treated with Inj. atropine 0.6 mg IV.

Rescue analgesia was with Inj. diclofenac 75 mg IM in the post operative period for a VAS score >4 and the time for the same was noted. Complications such as sedation, vomiting, shivering, pruritus, respiratory depression, if any, in the post operative period were noted in a prepared proforma.

Statistical Analysis

Data entry was done in Microsoft Excel and analyzed by Statistical Package for the Social Sciences (SPSS) software version 20.0. Continuous data was expressed in mean±SD and categorical data was expressed in count (%) respectively. Student’s t-test was used to test significance for a continuous variable across two groups. Chi-square’s test was used to test significance across categorical variables. The p-value <0.05 was considered as statistically significant.

Results

Both the groups of patients were comparable with respect to age, sex, height and body weight characteristics. There was also no significant difference in the type or duration of surgery (Table/Fig 3).

Sensory block characteristics: The mean onset time to T10 dermatomal level was similar in groups C and F (2.12±0.22 min vs 2.24±0.66 min). The mean maximum sensory block height achieved of T6 and the time to achieve the same (4.94±0.91 vs 5.12± 1.38min) was also similar in group C and group F patients (Table/Fig 4).

Group C patients took longer time for regression of sensory block by two segments to T8 as compared to group F (115.07±6.69 min vs 76.3±10.72 min). The total regression time to S1 also was prolonged in group C (148.5±10.84 min vs 109.37±14.5 min) in comparison to group F (Table/Fig 4).

Motor block characteristics: The onset of motor block was slow and time to achieve a complete motor blockade was also delayed in group C (3.22±1.01 min vs 1.16±0.3 min, 6.8±1.49 min vs 3.72±1.31 min) compared to group F. Complete motor blockade was achieved in all the patients (Bromage score 3). The recovery from motor blockade was also significantly delayed in group C when compared to group F (125.17±13.29 min vs 95.47±13.08 min (Table/Fig 5).

Time to first request for rescue analgesia in the recovery room was significantly delayed in the group C patients compared to group F patients (190.83±20.6 min vs 128.83±16.38 min) (Table/Fig 4).

Hemodynamic parameters: Basal Heart Rate (HR) and Mean Arterial Pressure (MAP) were found to be comparable in both group of patients. Heart rate was found to be lower in group C patients from the 1st minute post spinal to the end of surgery which was statistically significant when compared to group F though clinically none of the patients required correction with atropine. Similarly, there were statistically significant variation in the mean arterial pressures between both the groups at various time intervals (Table/Fig 6),(Table/Fig 7).

However, clinically significant hypotension requiring correction with mephentermine 6 mg occurred in nine patients in group C and in four patients in group F. Statistically, there was no significant difference in the number of patients developing hypotension in both the groups (p-value=0.117). All the patients in both the groups had a sedation score of 2 on Ramsay sedation scale and were awake and cooperative post spinal anaesthesia. Rest of the adverse effects such as nausea, vomiting, pruritus, shivering or respiratory depression did not occur in any of the patients in the postoperative period.

Respiratory parameters: At all points of time in the intra operative period, the oxygen saturation (SpO2) was between 99% and 100% in both groups of patients throughout the procedure and no significant difference between the groups (p-value >0.05).

Discussion

Ropivacaine is one of the popular intrathecal anaesthetics and is available as isobaric solution commercially. Intrathecal isobaric ropivacaine has been reported to cause inadequate or variable block (5). Addition of dextrose makes the drug hyperbaric which has been shown in various studies to produce a consistent block and less variation in sensory and motor block (6),(7),(8). Complete regression occurs sooner, thus patients can be mobilised sooner. However, these beneficial effects are offset by the perception of pain in the post operative period, hence, necessitating the use of intrathecal adjuvants. Clonidine, an α2 adrenergic receptor agonist by producing dose dependent analgesia and Fentanyl, a short acting opioid potentiating afferent sensory blockade, they facilitate dose reduction of intrathecal local anesthetics. Hence this study compared clonidine 15 mcg and fentanyl 25 mcg as additives to 0.42% hyperbaric ropivacaine.

In this study, the time of onset of sensory block, maximum height of block, and the time taken for maximum sensory block was similar in group C and group F. These findings were consistent with findings of Bathari R et al., (16) who compared 15 mg of hyperbaric ropivacaine with 30 mcg of fentanyl or 15 mcg of clonidine in their study. In yet another study by Chhabra A et al., (14), comparing 15 mg of 0.5% isobaric ropivacaine with 25 mcg of fentanyl or 60 mcg clonidine, the sensory onset and time taken for maximum sensory blockade was longer in both their groups compared to the current study. This could be due to the isobaricity of ropivacaine. Similar study using isobaric ropivacaine was done by Sharan R et al., where they also found that the onset time of sensory block in both clonidine and fentanyl groups were comparable; the maximum height attained was T6, similar to the present study (15). However, the time taken for attaining the maximum height was delayed in both clonidine and fentanyl groups. They compared 30 mcg clonidine and 25 mcg of fentanyl with 18.75 mg of isobaric ropivacaine. This delay could be explained due to the isobaricity of the study drug.

The sensory regression to S1 was delayed in group C (148.5±10.84 vs 109.37±14.5 min) compared to group F (p-value <0.05). However, in the study by Bathari R et al., (16), the sensory regression was prolonged and almost comparable in both the groups (262.5±37.7 vs 262.6± 44.67 min). The prolonged sensory blockade in their study could be due to the higher dose of Hyperbaric Ropivacaine 15 mg whereas we used only 10.5 mg and higher dose of Fentanyl of 30 mcg in their study versus 25 mcg in the present study.

Prolongation of sensory regression to L5 was more in the clonidine group when compared to fentanyl group which is similar to the findings by Chhabra a et al., (14). Similar findings of delayed sensory regression to L5 were seen by sharan et al., (15).

Onset of motor block and complete motor blockade in our study was faster in the group F compared to group C (1.16± 0.3 min vs 3.22±1.01 min, 3.72±1.31 min vs 6.8±1.49 min) respectively. Chhabra A et al., also reported early onset of and complete motor blockade in the fentanyl group compared to clonidine group (14). Shashikala TK et al., also reported early onset of motor block in their fentanyl group of patients (18).

Complete motor recovery was delayed in group C in the present study (125.17± 13.29 min vs 95.47±13.08 min) compared to group F. This is consistent with findings in the clonidine group versus fentanyl group in the study by Bathari R et al., (156±42.4 min vs 128.2±24.9 min) and in the study by Chhabra A et al., in the clonidine group versus fentanyl group (248.51± 55 min vs 212.60± 43.52 min) (14),(16).

Time for administering the rescue analgesic in the postoperative period was significantly prolonged in the clonidine group compared to the fentanyl group (190.83±20.6 min vs 128.83±16.38 min) in the present study. This is comparable with the findings of Chhabra A et al., (354±46.73 min vs 234.44±8.76 min) for clonidine and fentanyl group respectively (14). However, Bathari R et al., (16) found no significant difference in the time for post operative rescue analgesia in the clonidine and fentanyl groups (382.5±122.35 vs 390.5±82.5 min), respectively. This could be because of the higher dose of ropivacaine 15 mg and fentanyl 30 mcg in their study compared to 10.5 mg of Ropivacaine and 25 mcg of Fentanyl in the present study.

Hypotension was observed in nine patients in clonidine group and four in fentanyl group. Other adverse effects such as shivering, vomiting, pruritus or respiratory depression were not seen in any of the patients in both the groups.

Addition of clonidine and fentanyl to hyperbaric ropivacaine prolonged the duration of sensory anaesthesia without any effect on the onset of sensory or motor blockade, or any hemodynamic changes in this study.

Limitation(s)

Extreme caution is required while preparing the drug to prevent contamination. The exact density could not be measured, and only specific gravity of the prepared drug was measured, which is comparable with the specific gravity of hyperbaric solution mentioned in the literature available. Also, there is a difference in the total volume of the drug administered intrathecally after addition of adjuvants.

Conclusion

Spinal anaesthesia with 15 mcg of clonidine or 25 mcg fentanyl added to 0.42% hyperbaric ropivacaine improved the quality of sensory and motor blockade, significantly delayed the recovery time from sensory blockade thus prolonging the analgesia in the post operative period, effects being more prominently seen with clonidine than fentanyl. Additionally use of low dose of clonidine 15 mcg and fentanyl 25 mcg did not cause any significant hemodynamic changes or side effects, thus, rendering them as safe intrathecal adjuvants.

References

1.
Malinovsky JM, Charles F, Kick O, Lepage JY, Malinge M, Cozian A et al. Intrathecal anesthesia: Ropivacaine versus bupivacaine. Anesth Analg. 2000;91:1457-60. [crossref] [PubMed]
2.
Kallio H, Snall EV, Kero MP, Rosenberg PH. A comparison of intrathecal plain solutions containing ropivacaine 20 or 15 mg versus bupivacaine 10 mg. Anesth Analg. 2004;99:713-7. [crossref] [PubMed]
3.
Horlocker TT, Wedel DJ. Density, specific gravity and baricity of spinal anaesthetic solutions at body temperature. Anesth Analg. 1993;76(5):1015-18. [crossref] [PubMed]
4.
Chatterjee S, Bisui B, Mandal A, Sheet J, Sengupta S, Majumdar S, et al. Effects of intrathecal hyperbaric Ropivacaine versus hyperbaric Bupivacaine for lower limb orthopaedic surgery. Anesth Essays Res. 2014;8(3):349-53. [crossref] [PubMed]
5.
Fettes PDW, Hocking G, Peterson MK. Comparison of plain and hyperbaric solutions of ropivacaine for spinal anaesthesia. Br J Anaesth. 2005;94(1):107-11. [crossref] [PubMed]
6.
Lee a, Ray D, Littlewood DG. Effect of dextrose concentration on the intrathecal spread of amethocaine. Br J anaesth. 1988;61:135-38. [crossref] [PubMed]
7.
Whiteside JB, Burke D, Wildsmith JAW. Spinal anaesthesia with ropivacaine 5mg/ml in glucose 10 mg/ml or 50 mg/ml. Br J Anaesth. 2001;86:241-44. [crossref] [PubMed]
8.
Whiteside JB, Burke D, Wildsmith JAW. Comparison of ropivacaine 0.5% (in glucose 5%) with bupivacaine 0.5% (in glucose 8%) for spinal anaesthesia for elective surgery. Br J Anaesth. 2003;90:304-08. [crossref] [PubMed]
9.
McNamee DA, Mc Clelland AM, Scott S, Milligan KR, Westman L, Gustafsson U. Spinal anaesthesia: comparison of plain Ropivacaine 5 mg/ml with Bupivacaine 5 mg/ml for major orthopaedic surgery. Br J Anaesth. 2002;89(5):702-06. [crossref] [PubMed]
10.
Elia N, Culebras X, Mazza C, Schiffer E, Tramer MR. Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials. Reg Anesth Pain Med. 2008;33:159-67. [PubMed: 18299097]. [crossref] [PubMed]
11.
Kakunje R, Sethuramachandran A, Parida S, Bidkar PU, Talawar P. Effects of adding low dose clonidine to intrathecal hyperbaric Ropivacaine: A randomized double blind clinical trial. Anesth Essays res. 2016;10:38-44. [PMCID: PMC4767103] [PubMed:26957688]. [crossref] [PubMed]
12.
Hamber EA, Viscomi CM. Intrathecal lipophilic opioids as adjuncts to surgical spinal anaesthesia. Reg Anesth Pain Med. 1999;24(3):255-63. Doi: 10.1016/S1098-7339(99)90139-6. PMID:10338179. [crossref]
13.
Bachmann M, Laasko E, Niemi L, Rosenberg PH, Pitkanen M. Intrathecal infusion of bupivacaine with or without morphine for postoperative analgesia after hip and knee arthroplasty. Br J Anaesth. 1997;78:666-70. [PubMed: 9215016]. [crossref] [PubMed]
14.
Chhabra A, Jagtap SR, Dawoodi SF. Comparison of clonidine versus fentanyl as an adjuvant to intrathecal ropivacaine for major lower limb surgeries: A randomised, double-blind prospective study. Indian J of Pain. 2013;27(3):170-74. [crossref]
15.
Sharan R, Verma R, Dhawan A, Kumar J. Comparison of Clonidine and Fentanyl as adjuvants to ropivacaine in spinal anesthesia in lower abdominal surgeries. Anesth Essays Res. 2016;10(3):526-31. [crossref] [PubMed]
16.
Bathari R, Bhalotra A, Anand R, Kumar V. A randomised trial to compare the effect of addition of clonidine or fentanyl to hyperbaric ropivacaine for spinal anaesthesia for knee arthroscopy. South Afr J Anaesth Analg. 2016;22(1)20-24. [crossref]
17.
Gropper MA, Miller RD, Eriksson LI, Fleisher LA, et al. Miller’s Anesthesia. 9th Ed, Philadelphia PA: Churchill Livingstone/Elsevier. 2020, pg. 1432.
18.
Shashikala TK, Sagar SS, Ramaliswamy P, Hudgi VV. Comparing effects of intrathecal adjuvants fentanyl and dexmedetomidine with hyperbaric ropivacaine in patients undergoing elective infraumbilical surgeries. A prospective, doubleblind, clinical study. Anesth Essays Res. 2019;13:654-62. [crossref] [PubMed]

DOI and Others

DOI: 10.7860/JCDR/2022/56377.16341

Date of Submission: Mar 16, 2022
Date of Peer Review: Mar 31, 2022
Date of Acceptance: Apr 21, 2022
Date of Publishing: May 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Mar 25, 2022
• Manual Googling: Apr 15, 2022
• iThenticate Software: Apr 20, 2022 (6%)

ETYMOLOGY: Author Origin

JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com