| 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
|
|
|
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
|
|
|
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 |