| CTRI Number |
CTRI/2024/12/078128 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Propofol and Etomidate used for general anaesthesia for Smooth I-gel Insertion: A Study Using BIS Monitoring(for depth of anaesthesia) during General Anesthesia |
|
Scientific Title of Study
|
Evaluation of induction characteristics of Propofol and Etomidate for I-gel insertion using Bispectral Index (BIS) guided induction of General Anaesthesia. A prospective randomised double-blinded 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 |
Sai Mani Kanta Bandla |
| Designation |
Post Graduate |
| Affiliation |
All India Institute Of Medical Sciences, Rajkot |
| Address |
Department of Anaesthesiology ,opd block, room number 207,All India Institute Of Medical Sciences,Khanderi,Para Pipalaya ,Rajkot,360110
Guntur
ANDHRA PRADESH
522018
India |
| Phone |
9494526978 |
| Fax |
|
| Email |
saimanikanta.bandla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilasha Motghare |
| Designation |
Assistant Proffessor |
| Affiliation |
All India Institute Of Medical Sciences,Rajkot |
| Address |
Department of Anaesthesiology,opd block,room number 207, All India Institute Of Medical Sciences,Khanderi,Para Pipalaya ,Rajkot,360110
Rajkot
GUJARAT
360110
India |
| Phone |
9860819602 |
| Fax |
|
| Email |
pacaiimsrajkot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Mani Kanta Bandla |
| Designation |
Post Graduate |
| Affiliation |
All India Institute Of Medical Sciences,Rajkot |
| Address |
Department of Anaesthesiology ,opd block, room number 207,All India Institute Of Medical Sciences,Khanderi,Para Pipalaya ,Rajkot,360110
Rajkot
GUJARAT
360110
India |
| Phone |
9494526978 |
| Fax |
|
| Email |
saimanikanta.bandla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, All India Institute Of Medical Sciences, Khanderi,Para pipalaya,Rajkot,360006 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Department of Anaesthesiology |
| Address |
All India Institute Of Medical Sciences hospital,Khanderi,Para Pipalaya,Rajkot,360006 |
| 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 Sai Mani Kanta Bandla |
All India Institute Of Medical Sciences,Rajkot |
Depatrment of Anaesthesiology,opd block ,room number 207,All India Institute Of Medical Sciences,Khanderi,Para Pipalaya,Rajkot ,360110
Rajkot
GUJARAT |
09494526978
saimanikanta.bandla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute Of Medical Sciences,Rajkot,Gujarat |
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 |
| Comparator Agent |
Etomodate Infusion |
Etomidate Infusion at 200 ml/hour till BIS 50 |
| Intervention |
Prpofol Infusion |
Propofol infusion will be given at 200ml/hour till BIS 50 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA 1 and 2
2)BMI less than 35
3)Posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Posted for emergency surgery
2)Allergic to propofol and etomidate
3)Anticipated difficult airway
4)Adrenal insufficiency or seizure patients
5)Pregnant females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to achieve BIS50 |
Time taken to achieve BIS50 at baseline ,before start of induction agent infusion,before i gel insertion,1 minute after i gel insertion,3 minutes after i gel insertion,5 minutes after i gel insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dose required to achieve BIS 50
Igel ease of insertion characterstics
NOTE HEMODYNAMIC CHANGES |
Baseline(TS),Before insertion of i gel(TI),after insertion of i gel (1,3,5 MINUTES) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/12/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
•After
taking informed consent ,patients will be randomly assigned to one of the 2
group according to computer generated random number table.
Group
P – this group of participants will receive Infusion Propofol till BIS 50 is
achieved
Group
E – this group of participants will receive Infusion Etomidate till BIS 50 is
achieved.
•The
total time taken to reach BIS 50 will be calculated.
•Dose
required to achieve BIS 50 will be noted.
•Ease
of I-gel insertion by
degree of jaw relaxation and overall I-gel insertion conditions will be
assessed.
•Haemodynamic
changes and other adverse effects will be noted. |