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CTRI Number  CTRI/2026/01/101828 [Registered on: 22/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   The effect of total intravenous anesthetic agent propofol compared to the effect of inhalational anesthetic agent isoflurane on the recovery of the gut after the surgery . 
Scientific Title of Study   Effect of total intravenous anesthesia with propofol versus inhalational anesthesia with isoflurane on gastrointestinal recovery after laparoscopic surgery: A Randomised comparative observational 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  Dr Suvina N  
Designation  Associate Professor  
Affiliation  Dr B R Ambedkar medical college  
Address  Department of Anesthesiology,Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045
Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA
560045
India 
Phone  6366279888  
Fax    
Email  suvi11492@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suvina N  
Designation  Associate Professor  
Affiliation  Dr B R Ambedkar medical college  
Address  Department of Anesthesiology,Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045
Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045

KARNATAKA
560045
India 
Phone  6366279888  
Fax    
Email  suvi11492@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vridhi Rajan  
Designation  Assistant Professor  
Affiliation  Dr B R Ambedkar medical college  
Address  Department of Anesthesiology,Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045
Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA
560045
India 
Phone  9964059953  
Fax    
Email  vridhir@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr B R Ambedkar medical college  
Address  Dr B R Ambedkar medical college ,Kadugondanahalli, Bengaluru, Karnataka 560045 
Type of Sponsor  Private 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 Suvina N  Department of Anesthesiology   Dr. B.R. Ambedkar Medical College , Kadugondanahalli, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA 		 6366279888

suvi11492@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE(IEC)  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inhalational anesthesia using the anesthetic agent isoflurane   We are assessing the effect of inhalational anesthesia using the anesthetic agent isoflurane on gastrointestinal recovery immediate post surgery till 24hrs post surgery 
Intervention  Total intravenous anesthesia using the anesthetic agent propofol  We are assessing the effect of total intravenous anesthesia using the anesthetic agent propofol on gastrointestinal recovery immediate post surgery till 24hrs post surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective laparoscopic surgery under general anaesthesia lasting less than 120 minutes
2.Patients belonging to ASA- PS I- II
3.Body mass index less than 34
4.Patients aged 18-60 years  
 
ExclusionCriteria 
Details  1.Patients opting for open surgeries
2.Patients with known allergies to medications used in the study
3.Patients with long standing diabetes mellitus (more than 10 years)
4.Patients who refused to participate in the study
5.Patients with previously known GI dysfunction
6.Patients who are transferred to ICU post-operatively
7.Patients undergoing laparoscopic gynecological procedures
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for initial defecation and tolerance of solid food (SF+D) in both groups  Immediate post surgery till 24 hours post surgery time 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for first flatus in both groups  Immediate post surgery till 24 hours post surgery time 
I-FEED Score (intake, feeling nauseated ,emesis ,physical examination and duration of symptom manifestation)   It is recorded at 12, 24, 48hrs post operatively in both groups  
Gastric motility index through ultrasound guidance  Immediate post surgery till 24 hours post surgery period 
Post operative nausea vomiting   Immediate post surgery till 24 hours post surgery time 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   02/02/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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   Patients undergoing elective laparoscopic surgeries who fit the inclusion criteria are selected . They are divided into 2 groups. The first group is the patients receiving total intravenous anaesthesia with propofol and the second group is the patients receiving inhalational anaesthesia with isoflurane . We evaluate the gastric motility recovery of both the groups by assessing the time of first flatus, time of first solid tolerance , time of first motion and the ultrasound scan for the gastric motility index after 24 hrs of the surgery .After collecting this data, we will be comparing the data among the two groups . 
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