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CTRI Number  CTRI/2026/01/100715 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A research study that aims to comparative study of sevoflurane and isoflurane on hemodynamic stability on patients undergoing laparoscopic surgery. This study will help us understand which medication is more effective in reducing the stress response associated with these procedures. 
Scientific Title of Study   COMPARATIVE STUDY OF SEVOFLURANE AND ISOFLURANE ON HEMODYNAMIC STABILITY ON PATIENTS UNDERGOING LAPAROSCOPIC SURGERY: A RANDOMIZED CLINICAL TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
A/206/REB-Comm(SP)RIMS/2015/1289/11/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jiwanshu 
Designation  post graduate trainee 
Affiliation  Regional institute of medical sciences 
Address  Department of Anaesthesiology, RIMS, Imphal
Imphal west, Manipur, 795004
Imphal West
MANIPUR
795004
India 
Phone  9053174623  
Fax    
Email  jiwanshumehta777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ProfNAnita  
Designation  professor 
Affiliation  Regional institute of medical sciences 
Address  Department of Anaesthesiology, RIMS, Imphal
Department of Anaesthesiology, RIMS, Imphal, Manipur, 795004
Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jiwanshu 
Designation  post graduate trainee 
Affiliation  Regional institute of medical sciences 
Address  Department of Anaesthesiology, RIMS, Imphal
Department of Anaesthesiology, RIMS, Imphal, Manipur, 795004
Imphal West
MANIPUR
795004
India 
Phone  9053174623  
Fax    
Email  jiwanshumehta777@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology ,Regional Institute of Medical Sciences, Imphal,Manipur,India,795001 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West Manipur 795004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJiwanshu  Regional institute of medical sciences  Operation Theatre Complex Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West MANIPUR
Imphal West
MANIPUR 
9053174623

jiwanshumehta777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K811||Chronic cholecystitis, (4) ICD-10 Condition: K811||Chronic cholecystitis, (5) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INHALATIONAL AGENT ISOFLURANE  Study participants will receive isoflurane after securing airway by endotracheal tube,The anaesthetic concentration was adjusted to maintain minimum alveolar concentration 1.2 percent plus minus 0.2 percent for isoflurane, with titration based on the depth of anaesthesia, aiming to maintain MAP and heart rate within 20 percent of baseline. Duration 10 minutes before last suture . 
Comparator Agent  INHALATIONAL AGENT SEVOFLURANE  Study participants will receive sevofluane after securing airway by endotracheal tube,The anaesthetic concentration was adjusted to maintain 2 percent plus or minus 0.5 percent minimum alveolar concentration for sevoflurane, with titration based on the depth of anaesthesia, aiming to maintain MAP and heart rate within 20 percent of baseline.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex
Patients with ASA physical grade 1 and 2
Patients of age group 18 to 60 years
 
 
ExclusionCriteria 
Details  Difficult airway
Uncontrolled Hypertension
Uncontrolled Diabetes mellitus
Ischemic heart disease
Severe Renal disease
Cerebrovascular disease
Patients on beta blockers, alpha blockers
Bronchial Asthma
Allergy to study drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate hemodynamic stability during the induction, maintenance, and emergence phases of anesthesia   vitals including pulse rate, blood pressure, mean arterial pressure, and peripheral oxygen saturation assesed during operative period till 45 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
emergence time, extubation time, time to obey verbal commands, and time to achieve an Aldrete score of 9 or more than 9.  patient have to be monitored for 30 minutes in post operative room 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Laparoscopic surgeries have gained widespread acceptance across various surgical specialties due to their minimally invasive nature, reduced post operative pain, quicker recovery, and shorter hospital stays. Despite these advantages, laparoscopic procedures are associated with physiological alterations, including increased intraabdominal pressure and Carbon dioxide insufflation, which can pose significant challenges to maintaining hemodynamic stability during anesthesia. This becomes particularly important in patients safety and operative outcomes.

The present study is a prospective, randomized, and comparative clinical trial aimed at evaluating and comparing the effects of sevoflurane and isoflurane on intraoperative hemodynamic stability and post anesthesia recovery in patients undergoing various elective laparoscopic surgeries under general anesthesia.

A total of 84 patients, aged from 18 to 60 years and classified as ASA Grade I or II, scheduled for elective laparoscopic procedures, were enrolled in the study and randomly assigned into two equal groups

Group A    42 patients to receive sevoflurane for maintenance of anesthesia

Group B    42 patients to receive isoflurane for maintenance of anesthesia

All patients received standardized premedication and were induced with intravenous agents. Anesthesia was maintained with a mixture of oxygen and nitrous oxide , supplemented with either isoflurane or sevoflurane, titrated to maintain adequate depth of anesthesia by using MAC value and stable hemodynamic parameters.

Throughout the perioperative period, heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure were closely monitored. Postoperative recovery characteristics were also assessed, including

Time to eye opening

Response to verbal commands

Time to extubation

Modified aldrete score 

 
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