| CTRI Number |
CTRI/2025/06/089416 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
This study involved patients having keyhole gallbladder surgery under sevoflurane anaesthesia and compared how long it took to remove their breathing tubes after surgery to see how quickly they recovered from anaesthesia |
|
Scientific Title of Study
|
Comparison of tracheal extubation time using bispectral index versus end-tidal anaesthetic gas concentration monitoring in adults undergoing laparoscopic cholecystectomy under sevoflurane-based general anaesthesia |
| 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 Lalhmangaihzuali |
| Designation |
Postgraduate student |
| Affiliation |
ESI-PGIMSR, Basaidarapur |
| Address |
Department of anaesthesiology, Block C, ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110015
India |
| Phone |
7085645121 |
| Fax |
|
| Email |
lalhmangaihzualigangte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Thakur |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
ESI-PGIMSR, Basaidarapur |
| Address |
Department of Anaesthesiology, Block C, 2nd floor, ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110015
India |
| Phone |
9350103337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Thakur |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
ESI-PGIMSR, Basaidarapur |
| Address |
Department of Anaesthesiology, Block C, 2nd floor, ESI-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110015
India |
| Phone |
9350103337 |
| Fax |
|
| Email |
dranilthakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR, Basaidarapur, New Delhi, India - 110015 |
|
|
Primary Sponsor
|
| Name |
Dr Lalhmangaihzuali |
| Address |
ESI-PGIMSR, Basaidarapur, New Delhi, India - 110015 |
| 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 |
| Lalhmangaihzuali |
ESI-PGIMSR |
Department of Anaesthesiology, Block C, OT- 7 and 8, Basaidarapur
West
DELHI |
07085645121
lalhmangaihzualigangte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIMSR |
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 |
NA |
NA |
| Intervention |
Sevoflurane based general anaesthesia |
Anaesthesia will be given using Sevoflurane and Endotracheal tube will be inserted through the mouth and a Bispectral index sensor will be pasted on the forehead of the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 or 2
Surgery duration of 30 to 60 minutes |
|
| ExclusionCriteria |
| Details |
BMI>30kg/m2
Psychiatric disorders
Epilepsy
On chronic hypnotics/sedatives
Renal disease
Active neurological disease
Neuromuscular disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tracheal extubation time (in minutes) in BIS and ETAG group |
60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters in BIS & ETAG group |
At 0 & every 5 minutes till extubation of tracheal tube |
| Recovery time in BIS & ETAG group |
At 0 minute & every 5 minutes in the Post Anaesthesia Care Unit |
| Intraoperative awareness in BIS & ETAG group |
Within 12 to 24 hours after surgery |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="0"
Months="11"
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
|
This study is a prospective, randomized comparative study aimed at evaluating the difference in tracheal extubation time between bispectral index monitoring and end-tidal anaesthetic gas concentration monitoring in adult patients undergoing laparoscopic cholecystectomy under sevoflurane-based general anaesthesia. Sixty patients aged 18 to 60 years, classified as ASA grade 1 or 2, will be randomly assigned to either BIS or ETAG groups. Anaesthetic depth will be maintained using BIS values 40 to 60 or ETAG MAC levels 0.7 to 1.3. Extubation time will be recorded as the primary outcome. Secondary outcomes include comparisons of hemodynamic parameters, recovery time and intraoperative awareness. This study seeks to determine which monitoring method facilitates quicker and safer emergence from anaesthesia. |