| CTRI Number |
CTRI/2026/03/105428 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
IV Propofol vs. Sevoflurane Gas for Laparoscopic Gallbladder Surgery: A Comparison of Patient Recovery and Vital Signs. |
|
Scientific Title of Study
|
A STUDY TO COMPARE THE EFFICACY BETWEEN TOTAL INTRAVENOUS ANAESTHESIA WITH PROPOFOL AND BALANCED ANAESTHESIA WITH SEVOFLURANE IN TERMS OF RECOVERY PROFILE AND HEMODYNAMIC CHANGES DURING LARAROSCOPIC CHOLECYSTECTOMY- A RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHANDANA N P |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute
Fort, Krishnarajendra Road, Kalasipalya, Bengaluru
Bangalore KARNATAKA 560002 India |
| Phone |
9449527373 |
| Fax |
|
| Email |
chandananp07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Raghavendra B S |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute
Fort, Krishnarajendra Road, Kalasipalya, Bengaluru
Bangalore KARNATAKA 560002 India |
| Phone |
9902360703 |
| Fax |
|
| Email |
bsrags@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
CHANDANA N P |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute
Fort, Krishnarajendra Road, Kalasipalya, Bengaluru
Bangalore KARNATAKA 560002 India |
| Phone |
9449527373 |
| Fax |
|
| Email |
chandananp07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute
Fort, Krishna Road, Kalasipalya, Bengaluru, Karnataka, 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka, 560002 |
| 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 |
| DR CHANDANA N P |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 Bangalore KARNATAKA |
9449527373
chandananp07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Giving balanced anaesthesia using sevoflurane |
Giving balanced anaesthesia using sevoflurane |
| Intervention |
Giving total intravenous anaesthesia using propofol.
Dose 100-120 micrograms per kilogram per minute
given throughout the procedure to maintain plasma concentration of 1.5 to 2 microgram per millilitre |
Giving total intravenous anaesthesia using propofol.
Dose 100-120 micrograms per kilogram per minute
given throughout the procedure to maintain plasma concentration of 1.5 to 2 microgram per millilitre |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
Patients belonging to ASA Grade I, II,
Patients aged between 20 and 50 years of either sex,
Patient willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Heavy smoker (more than 20 cigarettes per day),
patients having hemorrhagic disorders or patients with anticoagulant therapy, other systemic disorders,
Patients on MAO-inhibitors, antidepressants and b-blockers,
Patient had general anesthesia within the past 2 weeks
Patients with history of allergy or sensitivity to volatile anesthetics or to propofol
Patients with body mass index more than 1.5 times normal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post-operative recovery profile between patients receiving propofol versus sevoflurane following laparoscopic cholecystectomy |
After Extubation 0 mins
Eye opening time 5-10 mins
Time for following verbal commands5-10 mins
Time for speaking name by patient5-10 mins
Time to achieve modified Aldrete score5-10 mins
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intra operative hemodynamic parameters, between propofol versus sevoflurane in patients undergoing laparoscopic cholecystectomy. |
intraop
Baseline
After intubation
Before pneumoperitoneum
After
pneumoperitoneum
10mins
20mins
30mins
Extubation
|
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
15/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study Title A randomized controlled study to compare the efficacy of Total Intravenous Anaesthesia TIVA using Propofol versus Balanced Anaesthesia using Sevoflurane on recovery profiles and hemodynamic stability in patients undergoing laparoscopic cholecystectomy Background and Justification Laparoscopic cholecystectomy is a common minimally invasive procedure yet it presents unique physiological challenges including hemodynamic fluctuations due to pneumoperitoneum and a high incidence of postoperative nausea and vomiting PONV While Sevoflurane is a standard inhalational agent known for its titratability Propofol based TIVA is theorized to offer superior hemodynamic stability and a smoother clearheaded recovery with reduced PONV This study aims to provide evidence on which technique optimizes patient outcomes in the perioperative period Objectives Primary To compare the recovery profile emergence time extubation time and cognitive recovery between the TIVA and Sevoflurane groups Secondary To evaluate and compare hemodynamic changes Heart Rate Mean Arterial Pressure at key intervals induction intubation pneumoperitoneum and extubation Tertiary To assess the incidence of postoperative side effects specifically PONV and shivering Methodology Study Design Prospective Randomized Controlled Trial RCT Participants Adults eg ASA physical status I and II scheduled for elective laparoscopic cholecystectomy Intervention Group A Total Intravenous Anaesthesia TIVA using Propofol infusion Comparator Group B Balanced General Anaesthesia using Sevoflurane with an oxygen nitrous oxide or air mix Standardization Both groups will receive standardized premedication analgesia eg Fentanyl and neuromuscular blockade Expected Outcome The study seeks to determine if Propofol based TIVA provides a more stable hemodynamic course during the stress of CO2 insufflation and results in a faster more comfortable recovery compared to Sevoflurane based inhalation anesthesia |