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CTRI Number  CTRI/2025/08/092822 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 10/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study of two types of anaesthesia for postoperative disorientation in young females undergoing laparoscopic gallbladder removal surgery 
Scientific Title of Study   Comparative analysis of isoflurane and propofol based total intravenous anaesthesia for postoperative delirium in young adults undergoing laparoscopic cholecystectomy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naven Baabu S 
Designation  Junior resident 
Affiliation  Banaras Hindu University Varanasi 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8939481416  
Fax    
Email  baabusumathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof A P Singh 
Designation  Professor 
Affiliation  Banaras Hindu University Varanasi 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9839412975  
Fax    
Email  bhuapsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof A P Singh 
Designation  Professor 
Affiliation  Banaras Hindu University Varanasi 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9839412975  
Fax    
Email  bhuapsingh@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India 
 
Primary Sponsor  
Name  Naven baabu S 
Address  Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India 
Type of Sponsor  Other [Self] 
 
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 Naven baabu S  Sir Sunderlal Hospital  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH 		 8939481416

baabusumathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee BHU Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Induction by Inhalational and Total Intravenous Anaesthesia  Induction by Isoflurane inhalational anaesthesia of Minimum Alveolar Concentration 1-1.5 to one group of participants and Propofol based Total Intravenous Anaesthesia of dose 4-12 mg per kg to other group of participants  
Comparator Agent  Inhalational anaesthesia by Isoflurane  Induction by Isoflurane based inhalational anaesthesia of Minimum Alveolar Concentration 1-1.5 
Comparator Agent  Propofol based Total Intravenous Anaesthesia  Induction by Propofol based Total Intravenous Anaesthesia of dose 4-12 mg per kg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. ASA 1 and ASA 2 patients
2. Patients scheduled for laparoscopic cholecystectomy
3. Patients between age 18 to 40 years of age and female sex
4. Written informed consent 
 
ExclusionCriteria 
Details  1. Presence of pre existing cognitive or neurological disorders.
2. Presence of emergencies or urgent surgeries.
3. History of substance abuse or dependence.
4. Presence of significant comorbidities e.g. severe cardiovascular disease, renal failure, advanced hepatic dysfunction, uncontrolled diabetes mellitus, severe respiratory disease, uncontrolled hypertension.
5. ASA grade 3 and 4
6. Pregnant or breast feeding
7. Concurrent surgeries
8. Inability to provide informed consent or participate in follow up.
9. Intra operative conversion to open cholecystectomy.
10. Receipt of regional anaesthesia techniques along side general anaesthesia. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
A prospective randomised control trial to compare the incidence of post operative delirium following laparoscopic cholecystectomy under Isoflurane inhalational anaesthesia and Propofol based Total Intravenous Anaesthesia.  The primary outcome will be the incidence of delirium with in first 2 post operative days. The delirium will be assessed by Confusion Assessment Method once a day between 3 pm to 5 pm. If the patient is discharged with in 2 days after surgery, the last assessment will be performed on the day of discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To observe duration , severity and type of post operative delirium.
2. To assess the post operative pain.
3. To record the frequency and dose of opioid rescue medication e.g. Morphine or Tramadol for breakthrough pain.  		 Observation of duration, severity and type of post operative delirium will be done with in first 2 post operative days and assessment of pain at 2, 6, 12, 24 hours post operatively by Visual Analog Scale. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   21/08/2025 
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="6"
Days="3" 
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  

This study is a double-blinded prospective randomized controlled trial comparing the effectiveness of Isoflurane inhalation anaesthesia and Propofol-based Total Intravenous Anesthesia (TIVA) for post operative delirium in young female patients (aged 18-40 years) undergoing laparoscopic cholecystectomy. The study will be conducted in the Department of Anaesthesiology at the Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will be the incidence of postoperative delirium within the first two days after surgery, assessed using the Confusion Assessment Method (CAM). Secondary outcomes include observation of duration , severity , type of delirium within first 2 post operative days and assessment of pain using the Visual Analog Scale (VAS) at 2, 6, 12 and 24 hours post operatively and documenting the frequency and dose of Opioid rescue medication ( Morphine or Tramadol) for break through pain if needed post operatively.

 
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