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CTRI Number  CTRI/2026/02/103667 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational comparative 
Study Design  Other 
Public Title of Study   Study of recovery after major gastrointestinal surgery using target controlled intravenous anesthesia during the maintenance phase of anesthesia 
Scientific Title of Study   EFFICACY OF TARGET CONTROLLED INFUSION FOR TOTAL INTRAVENOUS ANAESTHESIA (TCI-TIVA) ON RECOVERY PROFILE IN PATIENTS UNDERGOING MAJOR GASTROENTROLOGY SURGERIES 
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 Shilpi misra 
Designation  Professor(junior grade) 
Affiliation  Dr RML IMS, Lucknow 
Address  Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  9839932239  
Fax    
Email  drshilpi1980@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpi misra 
Designation  Professor(junior grade) 
Affiliation  Dr RML IMS, Lucknow 
Address  Department of Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  9839932239  
Fax    
Email  drshilpi1980@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashasti 
Designation  Junior resident 
Affiliation  Dr RML IMS, Lucknow 
Address  Anesthesiology and Critical Care Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  7376552883  
Fax    
Email  Prashasti99@gmail.com  
 
Source of Monetary or Material Support  
Dr RMLIMS,GOMATI NAGAR LUCKNOW,U.P,INDIA 226010 
 
Primary Sponsor  
Name  Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow, UP 
Address  Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, gomtinagar, Lucknow, Uttar Pradesh, 226010 
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 Shilpi misra  Dr. Ram Manohar Lohia Institute of Medical Sciences   OT3, OT4 of Department of Surgical Gastroenterology Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH 
09839932239

drshilpi1980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics commitee, Dr RML IMS Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual infusion based total intravenous anesthesia  General anesthesia will be maintained using manually controlled intravenous infusion of Propofol with opioid supplementation as per routine institutional practice. Drug dosing and infusion adjustments will be performed manually by the attending anesthesiologist based on clinical parameters. 
Intervention  Target controlled infusion based total intravenous anesthesia  General anesthesia will be maintained using target controlled infusion of Propofol and Remifentanil according to standard institutional practice. Drug infusion rates will be adjusted using a target controlled infusion pump to achieve desired anesthetic depth as decided by the attending anesthesiologist. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 65 years
ASA physical status I and II
Undergoing elective major gastroabdominal surgery under general anesthesia
Provided written informed consent 
 
ExclusionCriteria 
Details  Known allergy to propofol or remifentanil
Significant cardiac, hepatic, or renal disease
BMI more than 35
Surgery duration more than 8 hr
Neurological or psychiatric conditions
Pregnant or lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean time to extubation after discontinuation of Propofol and Remifentanil infusion  Measured from stoppage of anesthetic infusion to removal of endotracheal tube at the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Average intraoperative Bispectral Index values  Recorded at predefined intervals during the intraoperative period 
Intraoperative heart rate & mean arterial pressure  Recorded at baseline & at predefined intervals during surgery 
Time to return of spontaneous ventilation after discontinuation of anesthetic infusion  Measured from stoppage of anesthetic infusion until spontaneous respiratory effort is observed at the end of surgery 
Total intraoperative consumption of Propofol & Remifentanil during maintenance phase  Calculated at the end of surgery 
Incidence of postoperative nausea & vomiting  Within the first 24 hours after surgery 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   23/02/2026 
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="1"
Months="6"
Days="7" 
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   This study is designed to evaluate the efficacy of target controlled infusion total intravenous anesthesia using Propofol and Remifentanil on the recovery profile and perioperative stability of patients undergoing major gastroenterology surgeries.
Major abdominal surgeries are associated with significant physiological stress and require anesthesia techniques that provide stable hemodynamics, adequate depth of anesthesia, rapid recovery, and minimal postoperative adverse effects. Target controlled infusion systems use pharmacokinetic models to maintain a desired plasma or effect site drug concentration, allowing more precise titration of anesthetic agents compared to conventional manual infusion or inhalational anesthesia.
In this prospective clinical study, adult patients scheduled for elective major gastroenterology procedures under general anesthesia will receive anesthesia maintained with target controlled infusion guided Propofol and Remifentanil infusions according to standard institutional practice. Standard monitoring will be used, and intraoperative parameters such as heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide, and anesthetic drug consumption will be recorded at predefined intervals. The need for additional vasoactive drugs and intraoperative complications will also be documented.
Recovery characteristics will be assessed using objective measures including time to spontaneous breathing, extubation time, response to verbal commands, orientation. Total anesthetic drug consumption will be calculated, and postoperative side effects such as postoperative nausea and vomiting and other adverse events will also be noted. Postoperative outcomes such as pain scores, requirement of rescue analgesia, sedation level, and any respiratory or cardiovascular adverse events will be noted during the immediate postoperative period.
The results of this study will help determine whether target controlled infusion total intravenous anesthesia with Propofol and Remifentanil provides improved recovery quality and perioperative stability in major gastroenterology surgeries, potentially contributing to enhanced recovery protocols and better patient safety.
 
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