| CTRI Number |
CTRI/2026/02/104895 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing two methods of calculating how deep is the anaesthesia level in adult patients undergoing abdominal operations |
|
Scientific Title of Study
|
Corelation between BIS and MAC brain values at AI guided target end tidal sevoflurane levels: A clinical study in patients undergoing major abdominal surgery |
| 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 Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
Senior Consultant Room, Third Floor, Department of Anaesthesia, Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi 110085 |
| 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 Shagun Bhatia Shah |
Rajiv Gandhi Cancer Institute and Research Centre |
Operation Theatre no:2;Department of Anaesthesia;Operation Theatre Division; Third Floor ;Old Building; Sector-5;Rohini;Delhi-110085
North West
DELHI |
09891769779
drshagun_2010@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre, Delhi |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Weighing 45-80 kg
Undergoing major abdominal surgery lasting more than 5h
|
|
| ExclusionCriteria |
| Details |
Non-consent
History of seizures
Hypothyroidism
Respiratory dysfunction
Hepatorenal dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bispectral index |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MAC Brain |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| Heart rate |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| Mean arterial pressure |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| Pulse pressure variation |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| MAC Y |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| Target end tidal sevoflurane |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| Fraction of inspired sevoflurane |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
| End tidal sevoflurane |
Baseline (1min after endotracheal intubation)
Every 10 min after endotracheal intubation till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshagun_2010@rediffmail.com].
- For how long will this data be available start date provided 02-07-2027 and end date provided 01-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, observational, single arm, single centered cohort study comparing the depth of anesthesia values given by the bispectral index monitor with MAC brain values given by the anesthesia workstation in 40 consecutive adult patients undergoing major abdominal surgery lasting more than 5 hours. 40 ASA I-II patients of either sex, aged 18-70 years, weighing 45-80 kg shall be included in the study. Non consent, history of seizures, hypothyroidsm, respiratory dysfunction and hepatorenal dysfunction. Forty readings from each patient shall be analysed to yield 1600 data points. Our primary outcome measure would the bispectral index values measured at baseline and every 10 min thereafter post intubation till end of surgery. Our secondary outcome measures would be the MAC Brain values, heart rate, mean arterial pressure, pulse pressure variation, MAC Y, target end tidal sevoflurane, fraction of inspired sevoflurane and end tidal sevoflurane values measured at baseline, and every 10min thereafter, post intubation till the end of surgery. |