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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  
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 
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  
Status 
Not Applicable 
 
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
 
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