| CTRI Number |
CTRI/2026/02/104713 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of sleep-induction time between standard and diluted Propofol for patients undergoing tubal ligation surgery. |
|
Scientific Title of Study
|
Comparing Induction Time Of Standard Vs Diluted Concentration Of Propofol In Patients Undergoing Laproscopic Tubal Ligation A Randomized 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 |
Dr Dhanave Chakradhar Bhaskar |
| Designation |
Secondary DNB Student |
| Affiliation |
Dr.Baba Saheb Ambedkar Medical Collage And Hospital,Rohini,New Delhi |
| Address |
Operation Theatre,Main OT Complex,Anaesthesia Department 2nd Floor,Dr.Babasaheb Ambedkar Medical College and Hospital Sector- 6, Rohini, Delhi - 110085 North West, DELHI
North West
DELHI
110085
India |
| Phone |
9594992979 |
| Fax |
|
| Email |
chakradhardhanave@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetu Chaudhary |
| Designation |
Professor |
| Affiliation |
Dr.Baba Saheb Ambedkar Medical Collage And Hospital,Rohini,New Delhi |
| Address |
Anaesthesia Department
2nd floor, Hospital Building Dr.Babasaheb ambedkar medical collage and hospital,sector 6,Rohini,New delhi
North West
DELHI
110085
India |
| Phone |
7065023138 |
| Fax |
|
| Email |
dr.neetu.hrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetu Chaudhary |
| Designation |
Professor |
| Affiliation |
Dr.Baba Saheb Ambedkar Medical Collage And Hospital,Rohini,New Delhi |
| Address |
Anaesthesia Department 2 nd Floor,Hospital Building Dr.Babasaheb ambedkar medical collage and hospital,sector 6, Rohini,New delhi
North West
DELHI
110085
India |
| Phone |
7065023138 |
| Fax |
|
| Email |
dr.neetu.hrc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Babasaheb ambedkar medical college and hospital,rohini,delhi-110085 |
|
|
Primary Sponsor
|
| Name |
DrBabasaheb ambedkar medical college and hospital |
| Address |
Anaesthesia Department, 2nd Floor, Hospital Building Dr.Babasaheb Ambedkar Medical College and Hospital,sector-6,Rohini,Delhi,India -110085 |
| 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 Dhanave Chakradhar Bhaskar |
Dr.Babasaheb Ambedkar Hospital |
Operation Theatre,Main OT Complex,2nd Floor,hospital building,sector-6,Rohini,Delhi-110085
North West
DELHI |
9594992979
chakradhardhanave@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF DR BABA SAHEB AMBEDKAR HOSPITAL AND MEDICAL COLLAGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% Propofol |
1 ml 1% Propofol diluted with 1ml 5% Dextrose final concentration: 5 mg/mL
patients will received 0.5% propofol Intravenously in a syringe pump at 99ml/hour until loss of verbal response.
Time of beginning of infusion to time to loss of verbal response Will be induction time |
| Comparator Agent |
1% Propofol |
controlled group 1 ml 1% Propofol – final concentration 10 mg/ml
patients will received 1% propofol Intravenously in a syringe pump at 99ml/hour until loss of verbal response.
Time of beginning of infusion to time to loss of verbal response Will be induction time
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patients aged 18-45 years.
2.Scheduled for laparoscopic tubal ligation under general anaesthesia.
3.ASA physical status I or II.
4.Body Mass Index (BMI) 18–30 kg/m².
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to propofol, egg, or soy products.
2.Cardiovascular disease: uncontrolled hypertension, arrhythmias, ischemic heart disease.
3.Respiratory disease: severe asthma, COPD.
4.Hepatic or renal dysfunction.
5.History of difficult airway or anticipated airway problems.
6.Patients on medications that interfere with anesthetic drugs (e.g., chronic sedatives, anticonvulsants).
7.Any neurological or psychiatric disorder affecting assessment of consciousness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of beginning of infusion to time to loss of verbal
response will be induction time(min) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic changes like systolic & diastolic blood
pressure, heart rate, respiratory rate, pulse oximetry, endtidal-
carbon dioxide will be recorded before induction, at the end of
induction & 5 minutes after induction.
Any Episodes of apnea will be noted,apnea is defined as
observation of a cessation of breathing (10 or more
seconds) by the patient,which is confirmed using
capnography
Total dose of propofol required for induction recorded (mg/kg)
Injection pain will be assessed at the start of propofol
administration using a Visual Analog Scale (VAS 0–10). |
3 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 1 |
|
Date of First Enrollment (India)
|
07/03/2026 |
| 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)
|
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
|
- Limited data exist comparing 1% vs 0.5% propofol for induction characteristics & haemodynamic responses during laparoscopic procedures
- Many studies are underpowered for induction time, haemodynamic stability, recovery time, and adverse events, focusing mainly on injection pain. • Furthermore,there is little information on use of titrated doses of propofol for induction characteristics
- Methodological heterogeneity exists regarding pain on injection of propofol—such as differences in injection site, cannula size, premedication, and infusion rate—confounds interpretation, making it unclear whether observed benefits are due to dilution itself or to altered administration technique
- Hence, a well-designed randomized controlled study directly comparing 1% vs 0.5% propofol in laparoscopic tubal ligation is warranted to provide robust evidence for clinical practice.
- Study Area:
- The study will be conducted in the operation theatre complex, Department of Anaesthesiology & Critical care at Dr. Baba Saheb Ambedkar Medical college and Hospital, Sector-6, Rohini, Delhi.
- Primary Objective
- To compare the induction time of 1% versus 0.5% propofol during induction of anaesthesia in laparoscopic tubal ligation.
- Secondary Objectives
- To compare hemodynamic parameters( changes in HR, SBP, DBP, and MAP before induction,at the end of induction & 5 minutes after induction) and incidence of apnea
- To compare the total propofol dose required for induction
- To compare pain on injection among the two groups using a Visual Analogue Scale (VAS 010) measured at the time of infusion.
|