| CTRI Number |
CTRI/2024/03/063833 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study compares using brain activity measurements and the loss of verbal response to decide how much propofol should be given for anesthesia in adult patients undergoing elective surgeries. The research randomly assigned participants to different groups. |
|
Scientific Title of Study
|
“Comparison of electroencephalogram entropy versus loss of verbal response to determine the dosage of propofol for induction of general anaesthesia in adult patients undergoing elective surgeries †A randomised 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 |
KUSHAL YALABURGI |
| Designation |
Post Graduate student |
| Affiliation |
Bangalore Medical College and research institute |
| Address |
Post graduate resident Dept of anaesthesiology victoria hospital Bangalore Medical College Bangalore Karnataka 560018
Bangalore
KARNATAKA
560018
India |
| Phone |
9611682237 |
| Fax |
|
| Email |
kushal.yalaburgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendra B S |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and research institute |
| Address |
BMCRI Super Speciality
Hospital/PMSSY Hospital, Dept of Anaesthesiology , 5th floor ,Alur Venkata Rao Rd, New Tharagupet, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9902360703 |
| Fax |
|
| Email |
bsrags@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghavendra B S |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and research institute |
| Address |
BMCRI Super Speciality Hospital/PMSSY Hospital, Dept of Anaesthesiology, 5th floor . Alur Venkata Rao Rd, New Tharagupet, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9902360703 |
| Fax |
|
| Email |
bsrags@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
KUSHAL YALABURGI |
| Address |
Post graduate resident Dept of anaesthesiology victoria hospital Bangalore Medical College Bangalore Karnataka 560018 |
| 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 |
| Dr Kushal Yalaburgi |
Bangalore Medical College and Research Institute |
Pmssy hospital
Dept of anaesthesiology
5th floor
Bangalore
KARNATAKA |
9611682237
kushal.yalaburgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Bangalore Medical College and Research Institute |
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 |
Entropy monitoring |
Entropy monitoring, a combination of EEG and EMG measurements, will be used to assess the depth of anesthesia during the study. This involves applying a self-adhesive entropy sensor with three electrodes to the patients forehead to monitor hypnosis and anesthesia depth. The study aims to compare the effectiveness of entropy monitoring with the conventional clinical endpoint in guiding propofol administration. |
| Comparator Agent |
traditional method of determinig dosage of propofol by loss of response to verbal commands during induction of general anaesthesia |
traditional method of determinig dosage of propofol by loss of response to verbal commands during induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 60 YEARS
2. Patient willing to give informed consent and procedure as per the declaration of Helsinki guidelines
3. American society of Anesthesiologist Physical Status : ASA 1,2 in patients undergoing elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe cardiac disease, liver diseases and renal dysfunction.
2. Patients not willing to give informed consent.
3. Emergency procedures.
4. Patients with hearing disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. The dose of propofol required for induction of general anesthesia, as determined by EEG entropy and loss of verbal response. |
during induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Incidence of adverse events, such as hypotension, bradycardia during induction of anesthesia. |
one, five & 10 mins after induction of anaesthesia |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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="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
|
Pre
anesthetic evaluation and Selection of the patients.
Baseline measurement
of haemodynamic parameters and
induction of anaesthesia .
Assessment
of dosage of propofol required for
induction of general anesthesia during entropy/loss of verbal response.
Assessment
of patients haemodynamic parameters and
values of entropy intra operatively during the timings mentioned above.
Data
Analysis |