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CTRI Number  CTRI/2026/03/106791 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Bispectral Index Monitoring and conventional monitoring on consumption of isoflurane and recovery profile in general anaesthesia 
Scientific Title of Study   A randomized comparitive study to compare the efficacy of Bispectral Index Monitoring (BIS) with conventional monitoring on consumption of isoflurane and recovery profile in 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  Saloni Shah 
Designation  PG resident  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760, India

Vadodara
GUJARAT
391760
India 
Phone  9023975044  
Fax    
Email  salonishah573@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pooja Shah 
Designation  Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760, India

Vadodara
GUJARAT
391760
India 
Phone  9825031186  
Fax    
Email  poojapatwa249@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pooja Shah 
Designation  Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia, Vadodara, Gujarat, 391760, India

Vadodara
GUJARAT
391760
India 
Phone  9825031186  
Fax    
Email  poojapatwa249@gmail.com  
 
Source of Monetary or Material Support  
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia , Pipariya, Vadodara, Gujarat, India Pincode- 391760 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia, Pipariya, Vadodara, Gujarat - 391760 
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 Pooja Shah  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  2nd Floor, General O.T. Complex, Anaesthesia Department, Dhiraj hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodiya, Pipariya, Vadodara, Gujarat 391760
Vadodara
GUJARAT 
9825031186

poojapatwa249@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA Grades I and II were selected for study after ethical committee approval.
2. Patients undergoing elective general surgical procedures expected to last at-least
one hour under general endotracheal anaesthesia such as laparotomy, cholecystectomy, hemi-thyroidectomy procedures were included in the study. 
 
ExclusionCriteria 
Details  1. Patient refusal to participate in study
2. ASA grade III or higher
3. Patients with known neurologic disease
4. Patients with cardiovascular or metabolic diseases
5. Patients with impaired renal or hepatic function
6. Patients with history of alcohol or drug abuse
7. Patients with psychiatric illness.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy between Bispectral index monitoring and Conventional monitoring in decreasing inhalational agent
requirement, maintaining adequate depth of anaesthesia, early recovery from anaesthesia and lesser postoperative stay in PACU. 
Baseline,before induction and after intubation haemodynamic parameters of depth of anaesthesia and Isoflurane concentration 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   05/04/2026 
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 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  
A comparison between Bispectral Index monitoring and conventional monitoring on consumption of Isoflurane and recovery profile in general anaesthesia  a prospective randomized observational study. 

Objective
To evaluate the effectiveness of BIS monitoring in maintaining optimal depth of anesthesia compared to conventional clinical monitoring methods 
1 To compare the effectiveness of BIS monitoring with conventional monitoring for incidence of intraoperative awareness
2 To compare consumption of volatile anaesthetic agent Isoflurane between BIS monitored and conventionally monitored patients
3 To determine differences in recovery profiles including time to open the eyes following verbal command and extubation and Post Anaesthesia Care Unit stay
4 To examine whether BIS monitoring leads to improved hemodynamic stability during surgery compared to conventional monitoring
5 To explore the overall safety and clinical utility of BIS monitoring as an adjunct to standard anesthetic care

Inclusion criteria
1 Patients of ages 18 to 60 years who gave their consents
2 ASA Grades I and II were selected for study after ethical committee approval 
3 Patients undergoing elective general surgical procedures expected to last at least one hour under general endotracheal anaesthesia such as laparotomy cholecystectomy hemithyroidectomy procedures were included in the study

Exclusion criteria
1 Patient refusal to participate in study 
2 ASA grade III or higher 
3 Patients with known neurologic disease 
4 Patients with cardiovascular or metabolic diseases 
5 Patients with impaired renal or hepatic function 
6 Patients with history of alcohol or drug abuse 
7 Patients with psychiatric illness

We will be conducting this on 60 adults aged between 18 to 60 years belonging to grade I and II of American Society of Anesthesiologists classification who will undergo elective surgeries under general anesthesia They will be divided into 2 equal groups randomly
GROUP B monitoring of depth of anaesthesia and titration of inhalational agent Isoflurane is done using BIS monitor 
GROUP C Conventional monitoring methods used to assess anesthetic depth such as Clinical signs like movement tearing sweating and hemodynamic parameters like heart rate and blood pressure and end tidal CO2 concentrations

Intraoperatively Pulse Rate Blood Pressure SpO2 will be recorded at 10 minute intervals till the end of surgery BIS monitoring will be done in group B every 10 minutes till extubation
In group C concentrations of the volatile anesthetics will be adjusted according to standard clinical practice which will be to maintain hemodynamic stability and avoid patient movement with the aim of achieving surgical plane of anaesthesia and a rapid recovery after surgery
In group B the volatile anesthetics will be titrated to maintain a BIS value between 40 to 60 A BIS value between 40 to 60 is ideal for surgical plane of anaesthesia and is set as the target for titrating the volatile anaesthetics in group B

All patients will be mechanically ventilated to maintain an end tidal carbon dioxide concentration of 35 to 45 mmHg All inhaled anesthetics will be discontinued on completion of the skin closure and reversal will be done using Inj Glycopyrrolate and Inj Neostigmine intravenously at the end of surgery
In Conventional group extubation will be done based on clinical signs which is spontaneous breathing obeying commands and adequate tidal volume and duration of anaesthesia and surgery will be recorded
In BIS monitoring group required volatile anaesthetic will be recorded and requirement of Isoflurane will calculated by using EHRENWORTH AND EISENKRAFT formula 

Site of Study
Department of Anesthesiology
Dhiraj Hospital
SBKS Medical Institute and Research Centre
Piparia
Waghodia
Vadodara 

Study Design
Prospective randomized observational comparitive study

Study Duration
The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier

Likely outcome
This randomized comparative study will help us to compare the efficacy between Bispectral index monitoring and Conventional monitoring in decreasing inhalational agent requirement and maintaining adequate depth of anaesthesia and early recovery from anaesthesia and lesser postoperative stay in PACU
 
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