| CTRI Number |
CTRI/2025/08/093142 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two different methods for determining the depth of anesthesia during the initial phase of anesthesia in patients undergoing surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of Bispectral Index (BIS)-guided vs Clinically
guided propofol induction in Adult Patients undergoing
Elective Surgery under General Anaesthesia: A Prospective
Randomised Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAMEELA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RAJKOT |
| Address |
Department of Anesthesia, AIIMS Rajkot ,360006
Rajkot
GUJARAT
360006
India |
| Phone |
8555806771 |
| Fax |
|
| Email |
prameelab442@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sumit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anesthesia, AIIMS RAJKOT, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9968720446 |
| Fax |
|
| Email |
sumitbansal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Bansal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Department of Anesthesia,AIIMS Rajkot, 360006
Rajkot
GUJARAT
360006
India |
| Phone |
9968720446 |
| Fax |
|
| Email |
sumitbansal05@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rajkot, 360006, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Prameela |
| Address |
AIIMS Rajkot |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| PRAMEELA |
AIIMS RAJKOT |
Department of Anesthesia, AIIMS Rajkot ,360006
Rajkot
GUJARAT |
8555806771
prameelab442@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), AIIMS Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
50 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol infusion by Bispectral index. |
In OT, Baseline parameters NIBP, HR, ECG, SpO2 noted Preoxygenation by 100% O2 followed by IV Fentanyl 2 mcg/kg
1) Group C – This group of participants will receive propofol infusion during induction of general
anaesthesia at the rate of 30 mg/kg/hr till loss of verbal response
2) Group B – This group of participants will receive propofol infusion during induction of general
anaesthesia at the rate of 30 mg/kg/hr till BIS 50±2 is achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient ready to give informed written consent
Men and women aged 18 years and older
ASA physical status class I to III
Patient coming for elective surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Pregnant female
Lactating mother
Baseline BP and/or HR fall greater than 20% on induction
Emergency surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effectiveness of BIS guided vs clinical guided anaesthesia induction by measuring propofol requirement
|
Induction time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety profile of BIS guided vs clinical guided anaesthesia induction by measuring hemodynamic parameters |
Induction 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)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
The aim of my study is to evaluate the effectiveness and safety of clinical vs BIS guided anesthesia induction using propofol infusion The study aims is to give the correct dose of propofol which improves the hemodynamic profile of the patients , increase the post op recovery .•In OT, Baseline parameters NIBP, HR, ECG, SpO2 noted Preoxygenation by 100 percent O2 followed by IV Fentanyl 2 mcg/kg •In Group B, infusion at 30 mg/kg/hr till BIS 50 ± 2 •In Group C, Propofol infusion at 30 mg/kg/hr till loss of verbal reflex Atracurium 0.5 mg/kg , Endo Tracheal Intubation. Hemodynamic parameters and speed of anaesthesia induction to be recorded
|