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

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Dr Mohan Z Mani

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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."



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




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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




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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 : 2023 | Month : February | Volume : 17 | Issue : 2 | Page : UC05 - UC09 Full Version

Phenylephrine and Ephedrine for Prevention of Hypotension in Women during Lower Segment Caesarean Section under Spinal Anaesthesia: A Randomised Clinical Study


Published: February 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/59684.17438
Ulpesh Shelke, Shilpi Yadav, Vikram Vardhan, Varsha Vyas, Shailaja Sadawarte, Salman Mulla, Surekha Patil, Jayshree P Vaswani

1. Resident, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 2. Resident, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 3. Professor, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 4. Professor, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 5. Resident, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 6. Resident, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 7. Professor, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Navi Mumbai, Maharashtra, India. 8. Professor and Head, Department of Anaesthesiology, Schoo

Correspondence Address :
Vikram Vardhan,
Professor, Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Nerul, Navi Mumbai, Maharashtra, India.
E-mail: vikram15vardhan@gmail.com

Abstract

Introduction: Hypotension is the most common serious adverse event associated with Spinal Anaesthesia (SA) and is associated with nausea and vomiting leading to pulmonary aspiration, respiratory depression and cardiac arrest. Phenylephrine (PE) and Ephedrine (EP) are vasopressors commonly used for prevention of hypotension associated with SA.

Aim: To compare the efficacy and safety of PE and EP in prevention of hypotension induced by SA in women during Lower Segment Caesarean Section (LSCS) surgery.

Materials and Methods: The present randomised clinical study was conducted on 60 women, between 18-36 years of age and a Heart Rate (HR) of 60-100 per minute randomised to receive either 100 mcg Intravenous (i.v.) bolus of PE, or 12 mg i.v. of EP during intrathecal block. Women having intraoperative hypotension were injected additional doses of vasopressor. Cardiovascular parameters were recorded at baseline (before block) and then at 1, 5, 10, 15, 30, 40 and 60 minutes. Further, safety was also assessed based on hypotension events and adverse events reported during immediate postoperative period. Data analysis was done using IBM SPSS 17 and a p-value <0.05 was considered statistically significant.

Results: The mean age of the study participants in PE and EP group was 26.67±5.40 and 26.23±4.59 years, respectively. Significant differences were observed between PE and EP groups for change in Systolic Blood Pressure (SBP) after 1, 10, 30, 40 and 60 minutes. Overall, there was a slight fall in SBP with PE, whereas, with EP there was a slight rise in SBP. Also, the Diastolic Blood Pressure (DBP) was maintained with EP throughout the 60 minute period, whereas with PE there was an initial rise in DBP followed by a slight fall in DBP. The Mean Arterial Pressure (MAP) was well-maintained with PE throughout, whereas with EP there was a fall in MAP after 15 minutes. However, these changes were not clinically significant. The Pulse Rate (PR) was lower with PE compared to EP group at time points of 1, 5, 15 and 20 minutes. The mean respiratory rates and blood oxygen saturation were similar with PE and EP administration (p>0.05). A total of 13 (43.3%) patients in the PE group and 14 (46%) in the EP group had adverse events excluding hypotensive patients.

Conclusion: According to the findings of the present study, the i.v. bolus of 100 mcg PE and 12 mg EP administered immediately after SA are equally effective in prevention of maternal hypotension and do not cause any significant cardiovascular and respiratory effects.

Keywords

Analgesia, Blood pressure, Haemodynamic, Perfusion index, Side-effects

Spinal Anaesthesia (SA) is the preferred anaesthetic procedure used in women posted for LSCS, and single shot SA is the most commonly used technique because of its distinct advantages (1). During SA, the mother does not lose consciousness, which decreases the issues related to airway management, and avoids potentially harmful effects of general anaesthesia on the foetus. SA is a reliable method and provides fast and profound symmetrical sensory and motor block and uses lower doses of local anaesthetics compared to epidural anaesthesia (2).

However, it also causes hypotension as the most common serious adverse event with a reported incidence of more than 80% (3). Hypotension with SA is especially associated with nausea, vomiting, and in more severe cases there may be risks of decreased consciousness, pulmonary aspiration, respiratory depression, and cardiac arrest. Maternal hypotension can have detrimental effects on the neonate due to reduced uteroplacental flow, foetal hypoxia, asphyxia and acidosis (4),(5). Also, spinal block is associated with precipitous hypotension and poor extent of analgesia.

Several strategies for preventing and treating hypotension are investigated, like the use of lateral uterine displacement (6), i.v. fluid preloading (7), gravity (8), compression devices on legs and prophylactic vasopressors, but none of them are proven to be satisfactory (9). Preloading or co-loading is commonly administered, but it has controversial results (10). Most often, the non pharmacological techniques fail to manage hypotension, and a vasopressor is usually required during SA. Vasopressors like EP, PE and metaraminol are commonly used for preventing hypotension during SA. However, selection of appropriate vasopressor in obstetrics depends on several factors like efficacy, non cardiovascular maternal effects, ease of use, foetal effects, cost and availability. PE is a potent directly acting adrenergic alpha receptor agonist used in hypotensive states. However, high doses of PE may be required in pregnancy, because of physiological changes in pregnancy (11). Also, foetal complications like acidosis have not been reported, even with the high dose PE use in obstetric practice (12).

Ephedrine, a sympathomimetic amine is the most used vasopressor which acts indirectly by increasing the release of noradrenaline at the postsynaptic α and β receptors (13). It also has a direct agonistic action on both α and β receptors. It increases the blood pressure by β1 adrenergic receptor stimulation with increased HR and cardiac contractility, whereas the α adrenergic receptor agonist action causes peripheral vasoconstriction. EP is administered as 6-12 mg i.v. bolus for the treatment of hypotension following SA.

The drug not only has a delayed onset of action, but also has a longer duration of action upto 60 minutes (14). Repeated use of EP is associated with depletion of endogenous norepinephrine stores leading to rapid tolerance (tachyphylaxis) (15).

Studies have compared maternal and foetal effects of i.v. PE and EP administration during spinal anaesthesia for caesarean delivery in high-risk pregnancies at various doses of the drugs. These reports suggest that both PE and EP can be safely used to counteract hypotension after spinal anaesthesia in patients with uteroplacental insufficiency, pregnancy-induced hypertension, and in non elective caesarean deliveries (16),(17),(18),(19),(20). Different vasopressors are commonly used at present with varying degrees of success (21). Despite the use of prophylactic i.v. infusion or bolus EP for the last three decades, a sizeable number of failures have also been reported and a rescue PE bolus dose appears effective when EP alone fails to correct hypotension (22),(23),(24),(25).

Prophylactic PE infusion significantly lowers the incidence of SA induced maternal hypotension despite its limitations like bradycardia, hypertension and reduced Cardiac Output (CO) at higher dose (26),(27). Due to this reason, previous researches focused on finding adequate preventive measure for hypotension from LSCS. However, the best prophylaxis of maternal hypotension during caesarean section is still under research. This randomised study compared the efficacy and safety of 100 mcg PE versus 12 mg EP dose that remains unexplored in preventing SA induced hypotension during LSCS. The primary efficacy outcome was the incidence of hypotension during the period of 60 minutes after administration of SA. The secondary outcomes were repercussion on SBP, DBP, MAP, HR, Perfusion Index (PI), Respiratory Rate (RR) and blood oxygen saturation (SpO2).

Material and Methods

This randomised clinical study was conducted during August 2018 to March 2019 in the Department of Anaesthesia, Dr. D.Y. Patil Hospital, Dr. D.Y. Patil Deemed University, School of Medicine, Navi Mumbai, Maharashtra, India. The study documents were reviewed and approved by the Institutional Ethics Committee (PDDYPMC/Ethic/PG Dissert/2017, Dated 10.10.2017). Informed written consent was obtained from all participating women prior to any study related procedure.

Sample size calculation: A sample size of 60 was decided for the study purpose on the basis of calculation using Medcalc version 12.0.3 software, with error of 5%, and a confidence level at 95%.

Inclusion criteria: Full-term pregnant women between 18-36 years of age, who were scheduled for elective LSCS under SA, with physical status ASA-II were screened for study eligibility. All women with a basal HR of between 60-100 beats per minute were enrolled in the study.

Exclusion criteria: Women with use of any opioids or sedatives, or a history of alcoholism were not included. Also, women having any abnormalities of thyroid, cardiopulmonary, liver, kidney, those with neurological conditions, or having tremors or fever or any active infection were also excluded.

Eligible women were randomised in a 1:1 ratio to receive either PE or EP based on a predetermined computer-based randomisation (Rando V 1.2, © R. Raveendran 2004). The study team received the randomisation codes in separate envelopes for each study participant and were instructed to open the envelope only after assigning the study number to the eligible participant. The investigator and study team were blinded to treatment allocation.

There was no data loss, and data of all sixty patients was used for final analysis (Table/Fig 1).

Study Procedure

Detailed preanaesthetic check-up of all the patients posted for LSCS surgery was done a day prior to surgery. All the patients were fasted for more than 8 hours prior to surgery. Vital parameters were measured at baseline before administration of SA. SA (intrathecal) was administered with a 23/25-gauge Quincke spinal needle, in a sitting position, at the L3-4/L4-5 interspace (mid line approach) with 2 mL bupivacaine (0.5%, heavy). Women were continuously monitored for occurrence of any hypotensive events (a decrease below 80% baseline and the combined definition of a blood pressure below 100 mmHg or a decrease below 80% baseline was defined as hypotension). After one minute of SA, 30 random women received 100 mcg i.v. bolus of PE and the other 30 women received 12 mg i.v. bolus of EP. Only in case of further rescue management if required, a rescue bolus dose of 50 mcg of PE and rescue dose of 6 mg EP was given to their respective groups. SBP, DBP, MAP, and PR were recorded at 0 (baseline), 1, 5, 10, 15, 20, 30, 40, 50 and 60 minutes.

Outcome measures: The primary efficacy outcome was the incidence of hypotension during the period of 60 minutes after administration of SA. Secondary efficacy outcomes were SBP, DBP, MAP, HR, PI, RR and SpO2. Safety outcomes were the adverse events recorded during intraoperative period and upto 24-hrs postoperative period.

Statistical Analysis

Measurement data for the SBP, DBP, MAP, PI, PR, RR and SpO2 are expressed as means± SD. Similarly, change from the baseline was computed for all measurement variables at each time point and expressed as mean±standard deviation (Mean±SD). A repeat-measures Analysis of Variance (ANOVA) was used to analyse the difference between the two groups for all cardiovascular parameters. Differences between the two groups (PE and EP) are computed for each variable at each time point and presented as means with 95% Confidence Intervals (CI). Categorical data and discrete data are expressed as numbers with percentages (proportions). Data analysis was done using a windows based statistical program IBM SPSS 17 (IBM Corporation, Armonk, New York, US). All measurement data was compared between the two groups using an unpaired t-test. Categorical data is compared between the two groups using an Chi-square test. All testing was done using two-sided tests at alpha 0.05. A p-value of <0.05 was considered significant.

Results

The two groups were similar with respect to the demography, level of anaesthesia and baseline values for vital parameters (Table/Fig 2). Hypotension was observed in only 6 (20.0%) patients with PE and 4 (13.3%) patients with EP (OR=1.625; 95% CI=0.408 to 6.469; p=0.488). (Table/Fig 3) presents the adverse events observed during the intraoperative and upto 24 hours postoperative period.

Most common events reported were vomiting and nausea accounting for about 30% events. The profile of adverse events was similar in the two groups (p=0.538). The RR and SpO2 were maintained in all the patients throughout the study period with no significant difference between the two groups (p>0.05).

Systolic Blood Pressure (SBP)

(Table/Fig 4) presents the SBP at different time intervals in both the groups. The baseline mean SBP was similar to PE and EP (p=0.328). However, at a time interval of one minute, the mean SBP was lower in the PE group compared to the EP group. In both the groups, mean SBP was fluctuating from baseline at different time intervals, but there were significant differences between the two groups (p<0.05). Overall repeat-measures ANOVA showed no differences between the two groups (p>0.05). Significant differences were observed between PE and EP for change in SBP after one minute (p=0.006), 10 minutes (p=0.013), 30 minutes (p=0.031), 40 minutes (p=0.020), and 60 minutes (p=0.033). Thus, overall, there was a slight rise in SBP with PE, whereas with EP there was a slight fall in SBP.

Diastolic Blood Pressure (DBP)

(Table/Fig 5) presents the DBP at different time intervals in both the groups. Baseline mean DBP was similar with PE and EP (p=0.350). However, the mean DBP was lower in the PE group compared to EP group at time intervals of one minute (p=0.105), five-minutes (p=0.006) and 10 minutes (p=0.074). After 15 minutes onwards the mean DBP was higher in PE group as compared to EP group, and these differences were statistically significant (p<0.05) except for 15 minute time period (p=0.067). However, significant differences were observed between PE and EP for change in DBP from baseline after five minute (p<0.0001), 15 minutes (p=0.002), 20 minutes (p<0.0001), 30 minutes (p<0.0001), 40 minutes (p<0.0001), and 60 minutes (p<0.0001) (Data not shown in table). ANOVA showed no differences between the two groups (p>0.05). Thus, overall, the DBP was maintained with EP throughout the 60-minute period, whereas with PE there was an initial rise in DBP followed by a slight fall in DBP.

Mean Arterial Pressure (MAP)

(Table/Fig 6) presents the MAP at different time intervals in both the groups. The MAP was similar with PE and EP at baseline (p=0.245) and upto 10 minutes (p>0.05). However, from 15 minutes onwards, the MAP was lower with EP than PE (p<0.05). Overall repeat measures ANOVA showed no differences between the two groups (p>0.05). The change in MAP from baseline was similar (p>0.05) with PE and EP at one minute, five minutes and 10 minutes.

However, the change in MAP was significantly different (p<0.0001) in PE and EP from 15 minutes onwards. Overall, the MAP was well-maintained with PE throughout the study period, whereas with EP there was a fall in MAP after 15 minutes.

Pulse Rate (PR)

(Table/Fig 7) presents the PR at different time intervals in both the groups. The baseline mean PR was similar to PE and EP (p=0.261). However, at time points of 1, 5, 15, 20 minutes, the mean PR was lower with PE compared to the EP group (p<0.05). However, at all other time points, minor changes were observed in the PR from baseline, which were not significant (p>0.05). Overall, repeat-measures ANOVA showed no differences between the two groups (p>0.05). There was a fall in PR with PE starting at 15 minutes, whereas there was a rise in PR with EP from one minute till 20 minutes. A slight fall in PR was observed with EP after 40 minutes. However, the change in PR from baseline between the groups was not similar at one minute (p<0.0001), 5 minutes (p=0.001, 10 minutes (p=0.020), 15 minutes (p=0.001), 20 minutes (p=0.012), and 60 minutes (p=0.035) (Data not shown in table).

Perfusion Index (PI)

(Table/Fig 8) Baseline mean PI was similar to PE and EP (p=0.223). However, at a time interval of 40 minutes, the mean PI was lower in the EP group compared to the PE group (p=0.017). At all other time-points, minor changes were observed in the PI from baseline, which were not significant (p>0.05). Overall, repeat-measures ANOVA showed no differences between the two groups (p>0.05). The PI increased with both PE and EP at all time points. However, the change (increase) in PI was greater with PE as compared to EP at 5, 10, 30, 40 and 60 minutes (p<0.05).

Discussion

The maternal hypotension during LSCS under SA for caesarean section is unacceptably high, despite preloading and lateral uterine displacement (28). Several mechanisms are proposed to be the cause of the hypotensive response after SA. First, sympathetic blockage from T1-L2 with subsequent arterial vasodilation leads to a reduction in Systemic Vascular Resistance (SVR), contributing to intraoperative hypotension. This decrease in SVR is often thought to be the main cause of hypotension after SA. Second, a decrease in venous vasomotor tone increases venous pooling and consequently reduces venous return, thereby decreasing CO. Finally, the physiological haemodynamic reserve capacity decreases with age, and limited cardiovascular compensation mechanisms contribute to a decline in CO and blood pressure in response to SA (29). In addition, use of an opioid like fentanyl to local anaesthetic to improve the quality of intraoperative and postoperative analgesia can also contribute towards increased rate of maternal hypotension, but some believed it to be worth the risk (30).

In this study, the efficacy of prophylactic bolus of two vasopressors, PE and EP to prevent maternal hypotension was compared following SA in caesarean section. In present study, similar hypotension rates were observed with PE and EP (p=0.488), when administered prophylactically with SA. These results corroborate with the findings of other researchers which concluded that PE and EP are both suitable vasopressors for use in non elective caesarean sections (16),(18),(20). On the other hand, a randomised comparative study reported a greater effect of EP (1 mg/min. i.v. infusion) than PE (10 mcg/min. i.v. infusion) preventing maternal hypotension in healthy women undergoing elective LSCS under SA (31). Simon L et al., in their prospective observation real-world study reported that increasing the dose of the prophylactic bolus of EP to 15 or 20 mg significantly reduces the hypotension events without increasing the undesirable tachycardia (32). Ngan Kee WD et al., reported i.v. 30 mg dose of EP as the smallest effective dose for prophylaxis of hypotension during SA for caesarean delivery (33). However, Shearer VE et al., reported foetal hypoxia (umbilical artery blood pH <7.20) with 10 mg i.v. EP in women receiving regional anaesthesia (34). In similar lines, McGrath JM et al., showed that EP was superior to PE in restoring uterine blood flow and foetal oxygenation during ritodrine infusion and epidural anaesthesia-induced hypotension in gravid (35).

Overall, repeat-measures ANOVA, showed no significant difference between the two groups (p>0.05) with respect to PR and BP. However, PE caused a slight increase and EP caused a slight decrease in SBP and DBP, but these changes were not clinically significant to cause any intervention. Similarly, the MAP was also similar with PE and EP at different time-points with minor fluctuations, which were not clinically significant. Similarly, the RR and SpO2 were similar with PE and EP in our study.

A total of 13 (43.3%) patients with PE and 14 (46%) patients with EP group had experienced adverse events excluding hypotension. In the present study, lesser incidence of adverse events, especially nausea was observed when compared to those reported by Hall PA et al., (31). Balki M and Carvalho JCA reported that intraoperative nausea and vomiting can be best prevented by controlling hypotension, and antiemetics should be reserved for high-risk patients and for those not responding to routine measures (4).

Limitation(s)

Being a single-centre study, the findings of the study could not be generalised, as there are varied reports of comparative results with PE and EP for prevention of hypotension with SA since last three decades.

Conclusion

According to the present study results, the i.v. bolus of PE (100 mcg) and EP (12 mg) administered immediately after SA are equally effective in prevention of maternal hypotension and do not cause any significant cardiovascular and respiratory effects.

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DOI and Others

DOI: 10.7860/JCDR/2023/59684.17438

Date of Submission: Aug 16, 2022
Date of Peer Review: Sep 21, 2022
Date of Acceptance: Nov 09, 2022
Date of Publishing: Feb 01, 2023

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

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