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CTRI Number  CTRI/2026/01/101011 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Elderly patients came for Laparoscopic Surgeries and we used BIS monitoring in one group and no BIS monitoring in other group while giving Anaesthesia to study the quality of recovery.  
Scientific Title of Study   Comparative study of Bispectral Index Guided Vs Standardised Anaesthesia Management on early Post Operative Recovery in elderly patients undergoing prolonged laparoscopic surgeries 
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 Ananya Chaturvedi 
Designation  PG resident 1st year 
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  Anaesthesia Department Second Floor OT Complex Mahatma Gandhi Medical College and Hospital RIICO industrial Area Sitapura Jaipur
RIICO, Sitapura
Jaipur
RAJASTHAN
302022
India 
Phone    
Fax    
Email  ananyachaturvedi11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Sachdev 
Designation  Professor Department of Anaesthesia  
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan Jaipur RAJASTHAN 302022 India
RIICO, Sitapura
Jaipur
RAJASTHAN
302022
India 
Phone    
Fax    
Email  propresidentmgu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ananya Chaturvedi 
Designation  PG resident 1st year 
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  Anaesthesia Department, 2nd Floor OT complex, Mahatma Gandhi Medical College and Hospital RIICO industrial area Sitapura Jaipur
RIICO, Sitapura
Jaipur
RAJASTHAN
302022
India 
Phone  8696904410  
Fax    
Email  ananyachaturvedi11@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College And Hospital 
Address  RIICO INDUSTRIAL AREA, SITAPUR 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Chaturvedi  Mahatma Gandhi Medical College and Hospital  Anaesthesia Department, 2nd Floor OT Complex Mahatma Gandhi Medical College and Hospital RIICO industrial area Sitapura Jaipur
Jaipur
RAJASTHAN 		 8696904410

ananyachaturvedi11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  If BISPECTRAL INDEX guided Anaesthesia management is preventative for Early post operative complications in elderly 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BISPECTRAL INDEX GUIDED ANANESTHESIA   Anaesthetic agents used to maintain Depth of anaesthesia, measured by Bispectral Index strips at range 40-60 
Comparator Agent  Standardised Anaesthesia Management   Empirical use of Anaesthetic agents maintaining Depth of anaesthesia without use of Bispectral Index strips  
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Scheduled for elective laparoscopic surgery under general anesthesia
ASA physical status I to III
Expected anesthesia duration more than 3 hours 
 
ExclusionCriteria 
Details  History of severe psychiatric/neurological illness
Drug allergies
Drug or alcohol abuse
Major organ dysfunction
Pre-existing sleep disorders
Poor GCS
Inability to perform Assessment scores CAM and MMSE
Pregnant and lactating female 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post operative quality of recovery by QoR 15 score in between 2 groups, BIS guided and Empirically guided Anaesthesia management.  Post operative Day 1,2,3 
 
Secondary Outcome  
Outcome  TimePoints 
To compare intraoperative hemodynamic variables between the two groups  Intraoperative 
To assess time taken to emergence between 2 groups  Intraoperative  
To compare incidence of Post Operative Delirium using CAM score between
2 groups 		 Post operative Day 1,2,3 
To compare incidence of Post Operative Cognitive Dysfunction using
MMSE Scale between 2 groups 		 Post operative Day 1,2,3 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   21/01/2026 
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="1"
Months="6"
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  

One of the most crucial, yet modifiable, factors influencing postoperative outcomes is

the depth of anaesthesia. Traditional methods of estimating anaesthetic depth, based

on haemodynamic parameters and clinical signs, may sometimes be inadequate or

misleading in elderly patients due to blunted autonomic responses or age related

altered pharmacodynamics.

The Bispectral Index BIS monitor provides a quantitative, objective, real time

measure of the patient’s level of consciousness and helps titrate adequate depth of

anaesthesia, by analysing the Electroencephalogram EEG. BIS values range from 0

no brain activity to 100 fully awake, with optimal general anaesthesia depth

typically maintained between 40 and 60. Hence BIS monitoring helps avoid both

excessively deep as well as light levels of sedation causing awareness and stress

related complication.

In elderly patients, over sedation is particularly harmful, often leading to delayed

emergence, hypotension, post operative cognitive impairment, in the form ofPost

Operative Delirium, Post Operative Cognitive Dysfunction. Assessing

cognitive impairment through tools like Quality of recovery questionnaire QoR15,

Confusion assessment Method CAM score, Mini mental scale examination MMSE,

provide a better understanding of the post operative recovery profile.

In Prolonged laparoscopic surgeries, the response of the patient during intraoperative

positioning, usage of Carbon dioxide gas, and haemodynamic alterations, could all be

exaggerated when considered for an elderly patient.

Thus, it is crucial to have balanced and optimal anaesthesia management in elderly

patients to avoid complications in post operative care. BIS monitoring addresses these

challenges by helping anaesthesiologists maintain an optimal depth of anaesthesia,

minimising drug overuse while ensuring patient safety.

Hence, a randomised, prospective study is being proposed in MGH, to evaluate the

impact of using BIS monitoring guided anaesthesia in elderly patients undergoing

prolonged laparoscopic surgeries in comparison to empirically guided anaesthesia care


 
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