| 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
|
|
|
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
|
|
|
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. |