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

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Dr Mohan Z Mani

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Believers Church Medical College,
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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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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.
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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 : 2023 | Month : July | Volume : 17 | Issue : 7 | Page : UC10 - UC14 Full Version

Opioid-based Anaesthesia versus Opioid Free Anaesthesia in Laparoscopic Cholecystectomies: A Randomised Clinical Study


Published: July 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/64362.18152
Rashmi Pal, Santosh Rajput, KK Arora

1. Professor, Department of Anaesthesia, Mahatma Gandhi Memorial Medical College and M.Y. Hospital, Indore, Madhya Pradesh, India. 2. Postgraduate, Department of Anaesthesia, Mahatma Gandhi Memorial Medical College and M.Y. Hospital, Indore, Madhya Pradesh, India. 3. Professor and Head, Department of Anaesthesia, Mahatma Gandhi Memorial Medical College and M.Y. Hospital, Indore, Madhya Pradesh, India.

Correspondence Address :
Dr. Santosh Rajput,
Flat No. B-404, Raunak Pratham Peradise, Kanadia Road, Vaibhav Nagar, Indore-452016, Madhya Pradesh, India.
E-mail: santoshrajput.edu@gmail.com

Abstract

Introduction: Intravenous opioids have been frequently used to provide analgesia and supplemental sedation during general anaesthesia or monitored anaesthesia care. Opioid Free Anaesthesia (OFA) is a multimodal approach which combines different drugs likes lignocaine, dexamethasone, paracetamol and dexmedetomidine with different techniques- such as hypnosis, sedation, analgesia and sympatholysis. Thus, reducing and avoiding opioids perioperatively will lead to decrease in opioid related adverse effects with better postoperative outcomes.

Aim: To compare OFA and Opioid-based Anaesthesia (OBA) in terms of haemodynamic stability, speed and quality of recovery, postoperative pain score and analgesic requirement.

Materials and Methods: The present study was a randomised study conducted in the Department of Anaesthesiology, Mahatma Gandhi Memorial Medical Colledge, Indore, Madhya Pradesh, India, from June 2021 to September 2022. The study has enrolled 90 patients of American Society of Anaesthesiologists (ASA) Grade I, II, 20-60 years of age undergoing elective Laparoscopic Cholecystectomy (LC) were divided into OBA fentanyl and OFA-lignocaine and dexmedetomidine. A standard general anaesthesia protocol of the institute was followed. OBA group received fentanyl (2 μg/kg) over 10 minutes before induction of anaesthesia and OFA group received lignocaine (2 mg/kg) and dexmedetomidine (0.5 μg/kg) both intravenously over 10 minutes before induction of anaesthesia. In OFA group analgesia was maintained by infusion of lignocaine 2 mg/kg/hr and dexmedetomidine 0.5 μg/kg/hr, whereas in OBA group fentanyl 0.5 μg/kg was given whenever required till the gall bladder was resected. Postoperative intraperitoneal instillation of gall baldder fossa was done with 20 mL 0.5% bupivacaine. Intraoperative mean Heart Rate (HR) and Mean Arterial Pressure (MAP) were recorded. Postoperative speed and quality of recovery, pain score, analgesic requirements and incidence of Postoperative Nausea and Vomiting (PONV) were noted. Paracetamol 15 mg/kg was given intravenously whenever Numerical Rating Scale (NRS) score was ≥6. Comparison of means between the two groups was done using unpaired t-test, association between two non parametric variables was done using Pearson Chi-square (χ2 test) test.

Results: The mean age, sex, weight, ASA and duration of surgery were comparable in both the groups. The mean HR was significantly lower in OFA group compared to the OBA group at all the time points (p-value ≤0.05). The mean MAP was significantly lower in OFA group at induction, after trochar insertion, after abdominal deflation and after extubation. Although, postoperative speed of recovery was slower in OFA group, the overall quality of recovery was better. The postoperative pain score, analgesic requirement and incidence of nausea and vomiting were all significantly less in OFA group as compared to OBA group with p-values of 0.02, 0.001 and 0.02, respectively.

Conclusion: OFA is new anaesthetic approach that provides better perioperative haemodynamic stability, postoperative pain control with less PONV and thus can be used safely and successfully.

Keywords

Cholecystectomy, Dexmedetomidine, Fentanyl, Lignocaine

Opioids have long been used for providing analgesia during general anaesthesia and postoperative pain management. They are associated with nausea, vomiting, dizziness, constipation, respiratory depression, opioid-induced tolerance and hyperalgesia. The dose-dependent side-effects can be very disabling for the patient and can delay postoperative rehabilitation (1). Thus, there has been a consistent search for sparing techniques in anaesthesia. So OFA, a multimodal approach with the use of non opioid analgesics and sympatholytic medications can reduce the requirement for perioperative analgesics (2). The respiratory depression is most significant opioid side-effect (3). This is crucial for individuals with conditions including obesity, sleep apnoea, chronic obstructive pulmonary disease and surgeries that have a high incidence of postoperative respiratory failure (4). Indeed, modern postoperative analgesia is based on opioid sparing, synthetic opioids were widely adopted to limit the effects of hypnotic agents by reducing their doses, maintaining haemodynamic stability, reducing cardiac out putmaintaing coronary perfusion, spontaneous breathing and facilitating mechanical ventilation. By using Multimodal Analgesia (MMA) with an opioid-sparing strategy, OFA has been made practicable (2),(5). MMA is based on the synergistic combination of medicines with various mechanisms of action causing additive pain relief that targets various nociceptors throughout the pain pathway. Thus, the combination of medications and/or methods enables a good quality general anaesthesia without the use of opioids (6),(7). So far very limited studies have been done on opioid sparing techniques for general anaesthesia.

Since, OFA avoids opioid-related adverse effects, an OFA regimen consisting of dexmedetomidine and lignocaine infusions along with paracetamol as a co-analgesic can be an effective anaesthetic technique for patients undergoing LC compared to the standard OBA regimen (8),(9). It is also associated with intraoperative haemodynamic stability, lower postoperative pain intensity, lower analgesic requirements in the early postoperative period and less incidence of PONV and also enables earlier mobilisation with enhanced rehabilitation, faster discharge and improved patient satisfaction (10),(11).

Hence, the present study was done to compare OFA and OBA in terms of intraoperative haemodynamic stability, speed of recovery and postoperative pain score as primary measures and total requirement of postoperative analgesic (Paracetamol) and antiemetic (Ondansetron), quality of recovery, incidence of postoperative side-effects both postoperatively as secondary measures.

Material and Methods

This double-blind, randomised, clinical study was conducted in the Department of Anaesthesiology, Mahatma Gandhi Memorial Medical Colledge, Indore, Madhya Pradesh, India, from June 2021 to September 2022. The patient and the observer both were blinded in the study. Approval from the Institutional Ethics and Scientific Committee was obtained (Letter No. EC/MGM/JUNE 21-22, date: 9, June).

Inclusion criteria: ASA I,II patients aged from 20 to 60 years of either gender scheduled for LC under general anaesthesia were included in the study.

Exclusion criteria: Patients with allergy to study medication, history of analgesic dependence and opiate tolerance, epilepsy and psychiatric disturbances, pre-existing diseases like cardiopulmonary diseases, hepatic dysfunction, renal dysfunction, psychiatric illness, pregnancy and lactation were excluded from the study.

Sample size calculation: Sample size calculation was based on difference of means of two independent samples. The following formula was used for sample size estimation:

where ni is the sample size required in each group (i=1,2), α is the selected level of significance and Z 1-α/2 is the value from the standard normal distribution holding 1-α/2 below it, and 1-β is the selected power and Z 1-β is the value from the standard normal distribution holding 1-β below it. ES is the effect size=0.599, Sample size was calculated using G power, software version 3.1.9.2. The sample size obtained at 95% confidence interval with an 80% power of the study. Where a (type-I error rate)=0.05, b (power of the study)=0.8, non centrality parameter=2.8414, critical t=1.98, df=88. A total of 90 patients were included in the study.

Allocation: A thorough preanaesthetic evaluation was performed. Ninety patients satisfying inclusion criteria were randomly allocated by sealed envelope method into two groups with 45 patients in each. Opioid based (fentanyl) group-OBA and opioid free (lignocaine+dexmedetomidine) group-OFA (Table/Fig 1).

Procedure

On the day of the surgery, patient was allocated to the group as per randomisation and informed/written consent was taken. Standard 11fasting guidelines were followed. Patients were taught to express pain by using NRS depicted by a 10 cm line with 0 at one end and 10 at the other (12).

Baseline parameters HR, MAP and Oxygen Saturation (SpO2) and End Tidal CO2 (ETCO2) were recorded and the patients were pre-medicated with inj. midazolam 0.05 mg/kg intravenously and inj-glycopyrrolate 10 μg/kg intramuscularly 30 minutes before induction of anaesthesia. Inj. dexamethasone 0.2 mg/kg and inj. paracetamol 15 mg/kg were both given intravenouslyover 10 minutes (13). OBA group received fentanyl (2 μg/kg) over 10 minutes before induction of anaesthesia and OFA group received lignocaine (2 mg/kg) and dexmedetomidine (0.5 μg/kg) both intravenously over 10 minutes before induction of anaesthesia (14). Induction was achieved by inj. propofol 2.5 mg/kg intravenously in both the groups. In both groups, intubation of trachea was facilitated by inj. succinylcholine 1.5 mg/kg intravenously and the airway was secured by appropriate size Endo-Tracheal Tube (ETT). Anaesthesia was maintained with O2:N2O 50:50 and isoflurane 0.6-1.6 vol% in a titrated manner. Muscle-relaxation was maintained with inj. vecuronium 0.1 mg/kg, intravenously as loading dose followed by top-up doses (1/4th of loading dose) as and when required.

In OBA group, additional fentanyl 0.5 μg/kg was given whenever HR was above 20% of baseline or MAP increased by 20% of baseline. In OFA group, a continuous infusion of inj. dexmedetomidine was maintained at a rate of 0.5 μg/kg/h with inj. lignocaine 2 mg/kg/hr till the gallbladder was resected. After removal of gallbladder, intraperitoneal instillation of 20 mL of 0.5% bupivacaine was done in gallbladder fossa in patients of both the groups (15). At the end of surgery, reversal of neuromuscular blockade was done by inj. neostigmine 50 μg/kg and inj. glycopyrrolate 10 μg/kg intravenously. Tracheal extubation was performed when patients were conscious and achieved a regular spontaneous breathing pattern.

HR, MAP, SpO2 and ETCO2 were recorded at baseline, induction (after analgesic), induction (after propofol), after intubation, after trochar insertion, after CO2 insufflation, after abdominal deflation and after extubation. Postoperative pain scores were assessed using NRS at 4 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours, postoperatively. Inj. paracetamol was given 15 mg/kg intravenous bolus whenever NRS was ≥6 for the first 24 hours in both groups. Speed of recovery in terms of time to spontaneous eye opening and time to extubation after switching off inhalational anaesthetics agents was assessed (16). Quality of recovery was also recorded in two groups using a 15-item questionnaire (Table/Fig 2) (17),(18). In 24 hours the incidence of PONV and total postoperative antiemetic (ondansetron) used were also noted.

Statistical Analysis

After collecting the data, the statistical analysis was performed using Excel 2007 and IBM Statistical Package for the Social Sciences (SPSS) version-20.0. Appropriate test of significance was applied wherever necessary for calculating the p-values. Comparison of means between the two groups was done using unpaired t-test, association between two non parametric variables was done using Pearson Chi-square (χ2 test) test. Quantitative data were described using mean, Standard Deviation (SD) and range. Categorical data were presented as frequencies and percentages. Changes in intraoperative haemodynamics among the two groups were analysed with one-way repeated measures Analysis of Variance (ANOVA). The p<0.05 was considered statistically significant.

Results

The mean age, weight and ASA status of the patients were all comparable in two groups whereas a female preponderance was there in both the groups. The durations of surgery were also comparable in both the groups (Table/Fig 3).

The mean baseline HR and mean MAP were comparable between the two groups (p-value >0.05). The mean HR was significantly lower in OFA group compared to the OBA group at all the time points (p-value <0.05) (Table/Fig 4). Except for two time points (after intubation and after CO2 insufflation), the mean MAP was significantly lower in OFA group compared to the OBA group (p-value <0.05) (Table/Fig 5).

The mean baseline SpO2 and ETCO2 in patients of OBA group and OFA group were 98.08±0.87 versus 98.06±0.88 and 37.35±4.38 mmHg versus 36.91±4.24 mmHg respectively. Thereafter no significant changes were noted in both the values of two group at all points of time (Table/Fig 6),(Table/Fig 7).

The postoperative mean NRS score was found to be significantly lower in OFA group in comparison to OBA group at 4, 8, 12, 16, 20 and 24 hours postoperative (p-value <0.05) (Table/Fig 8). Thirteen (28.9%) out of 45 patients required paracetamol postoperatively in OFA group as compared to 31 (68.9%) patients in OBA group which was statistically significant (p-value <0.05) (Table/Fig 9). There were 14 (31.1%) patients in OBA group who had PONV compared to 5 (11.1%) patients in OFA group (p-value=0.020) (Table/Fig 9).

In present study, speed of recovery from anaesthesia i.e. mean time to spontaneous eye opening and to extubation in OBA versus OFA group were 23.58±3.27 minutes v/s 31.40±3.03 minutes and 27.16±3.01 minutes v/s 36.56±2.59 min respectively (p-value <0.05) (Table/Fig 10). The mean QoR-15 score was 24.58±1.76 in OBA group and 25.93±1.42 in OFA group which is significantly better in OFA group as compared to OBA group (p-value=0.001) (Table/Fig 11).

Discussion

The goal of providing OFA has been made possible by MMA. MMA is based on the synergistic use of drugs with different modes of action, leading to additive pain management that works at different nociceptors along the pain pathway. So, intraoperative anaesthesia evolved from single agent anaesthesia to opioid based anaesthesia and the multimodal or balanced anaesthesia (2). Now-a-days, balanced OFA is feasible as it allows opioid sparing and is based on the concept that one drug will not replace opioid, rather it is the association of drugs and/or techniques that allows a good quality general anaesthesia with no need for opioids (5). So the present randomised clinical study was conducted to compare two techniques i.e., OFA versus OBA for patients undergoing LC. The study findings showed that patients in OFA group had a better intraoperative haemodynamic stability than patients in OBA group. They also had lower pain scores with lesser postoperative analgesic requirement. Although the speed of recovery from anaesthesia was slower in OFA group as compared to OBA group due to sedative effects of dexmedetomidine, the overall quality of recovery was better in OFA group.

In the present study, intraoperative mean HR and mean MAP were significantly lower intraoperatively in OFA group compared to the OBA group and the differences were statistically significant (p-value <0.05) [Table/Fig-4,5]. These results were coherent with the findings of the study performed by Vora KS et al., in 70 patients scheduled for elective laparoscopic surgeries, who received bolus infusion of dexmedetomidine (Group D) or saline (Group S) 1 mcg/kg/h, followed by continuous infusion of the same at the rate of 0.5 mcg/kg/h, where intraoperative mean HR was found to be lower in Group D than Group S (p-value <0.05) (19). These results were contradictory with the findings of a study performed by Ahmed OH and Noor El-Din TM, in which 62 patients were scheduled for LC which compared fentanyl with the combination of dexmedetomidine, ketamine and paracetamol as anaesthetic adjuvant in perioperative analgesics (20). The intraoperative HR, mean BP were lower in OFA, although statistically insignificant. This could be because of ketamine used in their study which is a sympathetic stimulant. The better haemodynamic stability and lower reading of mean HR and mean MAP in the present study may be due to additive negative inotropic effects of lignocaine and sympatholytic effects of dexmedetomidine.

In the present study, mean NRS score were found to be lower in OFA group in comparison to OBA group at 4, 8, 12, 16, 20 and 24 hours postoperatively (p-value <0.05). In OFA group, 13 (28.9%) out of 45 patients required paracetamol postoperatively as compared to 31 (68.9%) patients in OBA group which is statistically significant (p-value <0.05). The results of the current study were nearly consistent with the study done by Shalaby M et al., on 80 patients scheduled for elective LC which showed that NRS scores were lower at 20 minutes, 60 minutes and six hours postoperatively in OFA group than the OBA group the difference was statistically significant (21). The results of the current study were again consistent with the study done by Toleska M and Dimitrovski A on 60 patients scheduled for elective LC, which compared general balanced anaesthesia with fentanyl (F-group) and opioid-free general anaesthesia (OFA-group) (22). In the postoperative period, patients in the fentanyl group had higher pain scores as compared to those in OFA group. The total opioid requirement in the postoperative period was significantly higher in the fentanyl group as compared to the OFA group.

The speed of recovery from anaesthesia in terms of mean time to spontaneous eye opening and mean time to extubation both were delayed in dexmedetomidine (OFA) group as compared to fentanyl (OBA) group which was statistically significant (p-value <0.05). These results were coherent with the findings of study performed by Siddiqui T et al., in patients posted for LC (23). Dexmedetomidine group had longer on table recovery time and time to discharge from Postanesthesia Care Unit (PACU) (p-value <0.001) as compared to fentanyl group. The slower speed of recovery from anaesthesia in OFA group in present study could be attributed to sedative and hypnotic effects of dexmedetomidine, which is an alpha-2 adrenergic agonist.

In the present study, mean QoR-15 score of 25.93±1.42 in OFA group was better than 24.58±1.76 in OBA group with a statistically significantly difference (p-value <0.05). QoR-15 score shows the overall quality of anaesthesia i.e., less PONV, less postoperative pain, early mobilisation and rehabilitation. The results of the current study were supported with a study conducted by Al Bahar MY et al., who compared the effectiveness of OA versus OFA on 60 morbidly obese patients undergoing LC under general anaesthesia (24). The patients of OBA group received general anaesthesia with propofol, muscle relaxant and fentanyl as the main anaesthetic adjuvant and analgesic and those of OFA group received general anaesthesia with propofol, muscle relaxant, dexmedetomidine, ketamine and lidocaine as anaesthetic adjuvant and analgesic. OFA provided perioperative haemodynamic stability, postoperative pain relief with less analgesic consumption, less incidence of PONV, acceptable patient sedation and satisfaction than that of the opioid based anaesthesia in morbidly obese patients.

In the present study, in OBA group 14 (31.1%) out of 45 patient required ondansetron postoperatively as compared to 5 (11.1%) patient in OFA group the difference being statistically significant (p-value=0.020).

Limitation(s)

The present study was done on ASA I,II group patients which limit the application of this protocol in practice setting with lower co-morbidities. So specific patient’s population those with obesity, obstructive sleep apnoea and chronic pain should be targeted specifically in future studies on more complex surgeries which require longer period of hospitalisation and recovery to allow better assessment of OFA effects.

Conclusion

From the observation and result of above study, it may be concluded that OFA eliminates opioid-related side-effects, provides better perioperative haemodynamic stability and postoperative pain relief with less analgesic requirement and less incidence of PONV in patients undergoing elective LC as compared to opioid based anaesthesia. Thus, it can be adopted as a feasible and emerging technique of general anaesthesia in future.

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DOI and Others

DOI: 10.7860/JCDR/2023/64362.18152

Date of Submission: Mar 29, 2023
Date of Peer Review: Apr 27, 2023
Date of Acceptance: Jun 05, 2023
Date of Publishing: Jul 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

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Apr 04, 2023
• Manual Googling: May 12, 2023
• iThenticate Software: Jun 02, 2023 (13%)

ETYMOLOGY: Author Origin

EMENDATIONS: 6

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