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CTRI Number  CTRI/2025/01/079631 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare recovery time from anaesthesia through different techniques 
Scientific Title of Study   TO COMPARE POSTOPERATIVE RECOVERY IN PATIENTS UNDERGOING TOTAL INTRAVENOUS ANAESTHESIA (Tiva) USING TARGET CONTROLLED INFUSION SYSTEM (TCI) AND CONVENTIONAL INTERMITTENT BOLUS TECHNIQUE  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himani Chauhan 
Designation  Resident Anaesthesia  
Affiliation  Command Hospital Air Force Bangalore  
Address  167/4 Golden Jubilee Officers Complex, Agram Post, Near Command Hospital Airforce Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  7895711136  
Fax    
Email  himanichamoli5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditya Sapra 
Designation  HoD, Department of Anaesthesia, CHAF Bangalore 
Affiliation  Command Hospital Air Force Bangalore  
Address  First Floor, Main Building, Department of Anaesthesia, Command Hospital Airforce Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  7895711136  
Fax    
Email  adityasapra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Himani Chauhan 
Designation  Resident Anaesthesia  
Affiliation  Command Hospital Air Force Bangalore  
Address  167/4, Golden Jubilee Officers Enclave, Agram Post, Near Command Hospital Airforce Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  7895711136  
Fax    
Email  himanichamoli5@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital, AirForce Bangalore, Cambridge Layout, Jogupalya, Karnataka, India Pin 560007 
 
Primary Sponsor  
Name  Command Hospital Airforce Bangalore  
Address  Command Hospital Airforce Bangalore 560007 
Type of Sponsor  Other [Government Hospital with PG seats] 
 
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 Himani Chauhan  Command Hospital Air Force Bangalore  First Floor, Main Building Department of Anaesthesia Command Hospital Air Force Bangalore
Bangalore
KARNATAKA 		 7895711136

himanichamoli5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinath R  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Total Intravenous Anaesthesia using conventional intermittent bolus technique  Total Intravenous Anaesthesia using conventional intermittent bolus technique Duration: less than 30 minutes Frequency: 3-5 minutes 
Intervention  Total Intravenous Anaesthesia using Target Controlled Infusion System  Total Intravenous Anaesthesia using Target Controlled Infusion System Duration- less than 30 minutes Frequency: once 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. All patient undergoing short gynecological procedures in ASA I and II

2. Informed consent 
 
ExclusionCriteria 
Details  1. Patients with BMI more than 30 kg per metre square

2. Allergy to propofol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare time and quality of post operative recovery in patients undergoing Total Intravenous Anaesthesia using Target Controlled Infusion system as compared to conventional Intermittent Bolus Technique  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total Drug(Propofol) used intra operatively in either technique
2. Periods of apnea/hypoxia in either technique

 		 12 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   05/02/2025 
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="1"
Months="0"
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  

AIM

To compare time to recovery from anaesthesia in patients undergoing ‘Total Intravenous Anaesthesia’ using ‘Target Controlled Infusion’ system as compared to conventional ‘Intermittent bolus technique’.

OBJECTIVE

Primary objective- To compare time and quality of postoperative recovery in patients undergoing ‘Total Intravenous Anaesthesia’ using ‘Target Controlled Infusion’ system as compared to conventional ‘Intermittent bolus technique’.

Secondary objectives

  • Total drug (Propofol) used intra operatively in either technique.
  • Periods of apnea/ hypoxia in either technique


7.1 SOURCE OF DATA:

The proposed randomized controlled study will be conducted in the Department of Anaesthesia at Command Hospital (Air Force) Bengaluru after obtaining permission from the Institutional Ethical Committee.

A total of 100 patients who are willing to give the consent and also satisfy the inclusion/exclusion criteria will be included in the study during the 12 months period from approval of the study.

 

METHODS OF COLLECTION OF DATA:

A. INCLUSION CRITERIA:

1.   All patients undergoing short gynaecological procedures in ASA grade I,II

2.   Willing for valid consent.

 

B. EXCLUSION CRITERIA:

1.   Obese patients with BMI more than 30kg/m2

2.   Allergy to Propofol

 

C. SAMPLE SIZE: 52

     Required sample for the group A = 26

     Required sample for the group B= 26

 

 METHOD OF COLLECTION OF DATA:

 

All enrolled patients will be visited and explained in detail about the anaesthetic procedure and written and informed consent will be obtained from patient and NOK wherever applicable. Detailed Pre Anaesthetic evaluation will be carried out. Appropriate laboratory and radiological investigation will be requested for and evaluated.

 

All the patients selected for the study will be advised to follow standard fasting guidelines.  Each day listed OT cases will be randomized into two groups A and B using computer generated random number tables. Group A will undergo Target Controlled Infusion [TCI]- Propofol Anesthesia while Group B will undergo Propofol intermittent bolus Anesthesia.

 

In both groups, IV access (18G/20G) will be secured. All patients, irrespective of their randomization group will be administered Injection Fentanyl 2 mcg/kg IV and Injection Glycopyrolate 0.2 mg IV. Monitoring will be done as per ASA minimum monitoring guidelines. In addition,  all patients will be monitored using Bispectral Index (BIS) monitor to enable an objective measurement of depth of anesthesia prior to initiation of procedure. It correlates well with the level of sedation produced by Propofol and is shown to reliably assess the depth of anaesthesia. A BIS recording of 80 is commonly accepted as an indicator of light sedation and a recording of 40 indicates a deep hypnotic state. Procedure will only proceed in both groups when BIS ≤40.  A baseline value of BIS prior to initiation of anaesthetic agent will be recorded. In addition, intra procedural hemodynamic parameters (HR, BP, and SpO2) will be recorded at 5 min intervals. Guidelines for safe practice of TIVA will be adhered to TIVA will be administered via peripheral intravenous access with a three-way cannula.

 

In the TCI group, patient parameters (height & weight) will be fed into the machine, which will be utilizing the modified Marsh’s Protocol for calculating appropriate dosing of Propofol. Time will be noted from initiation of Propofol to attainment of BIS≤40. Estimated plasma concentrations at this time will be displayed on TCI pump and will be noted.

 

In the ‘Intermittent Bolus’ group, patients will be given Injection Propofol as intermittent bolus to achieve a BIS≤ 40.

 

In both the groups, Infusion/ Bolus Injections will be stopped on completion of the procedure, and time taken for achieving BIS≥80 will be noted. This will be taken as the end point for recovery.

 

Outcomes Measures: Post-operative recovery in the form of BIS value of more than 80 after stopping infusion/last bolus injection.

 

 STATISTICAL ANALYSIS

Data collected will be entered in to MS Excel; tables and charts will be generated using MS Word. Qualitative variables and continuous variables will be presented using percentages and mean+/- SD. Mean differences in time will be compared using paired T -test P value <0.05 will be considered as statistically significant at 5% level of significance.

 
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