| CTRI Number |
CTRI/2024/10/075541 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of two methods for giving the drug propofol(drug for inducing anesthesia) in patients undergoing surgery under general anesthesia: one by manual infusion and another target controlled infusion |
|
Scientific Title of Study
|
Comparative Study of Manual Infusion with Target Controlled Infusion for induction with Propofol in Patients Posted for Surgeries Under General Anesthesia |
| 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 Pavan V |
| Designation |
Post Graduate Student |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Kodagu Institute of
Medical Sciences, Madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
9902869990 |
| Fax |
|
| Email |
pavanreddy.gcis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Kodagu Institute of Medical Sciences Madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Kodagu Institute of Medical Sciences Madikeri
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu Institute of Medical Sciences, Kodagu district Madikeri 571201 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Kodagu Institute of Medical Sciences |
| Address |
Kodagu Institute of Medical Sciences, Madikeri 571201 |
| Type of Sponsor |
Government medical college |
|
|
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 Pavan V |
Kodagu Institute of Medical Sciences Teaching Hospital |
Major OT complex,
room number 202,
Department of
Anesthesiology, Kodagu
Institute of Medical
Sciences Teaching
Hospital Madikeri
571201
Kodagu
KARNATAKA
Kodagu
KARNATAKA |
9902869990
pavanreddy.gcis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Kodagu Institute of Medical Sciences |
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 |
| Comparator Agent |
Delivery of intravenous Propofol |
By manual infusion pump based on weight at 2mg/kg
End point of induction will be taken as the time at which Bispectral Index reaches 60 |
| Intervention |
Delivery of intravenous Propofol |
By target controlled infusion
Infusion will be based on Schnider pharmacokinetic model by targeting a propofol plasma concentration of 4 mcg/ml
And point of induction will be taken as the time at which Bispectral IndexIndex reaches 60 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists physical status grade I and grade II
2. Elective OT cases under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Allergic to the study drug- Propofol
2. History of Asthma and Chronic obstructive pulmonary disease
3. History of any neurological disorder
4. History of Cardiopulmonary disease
5. Pregnant and lactating females
6. Difficult airway or difficult ventilation or difficult laryngoscopy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dose of propofol needed for induction by manual infusion and Target Controlled Infusion |
Frequency |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variability in both the groups |
Frequency |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
28/10/2024 |
| 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
|
COMPARATIVE STUDY OF MANUAL INFUSION WITH TARGET CONTROLLED INFUSION FOR INDUCTION WITH PROPOFOL IN PATIENTS POSTED FOR SURGERIES UNDER GENERAL ANAESTHESIA Patients who meet the inclusion and exclusion criteria will be randomised into 2 groups T group – patient receiving propofol through target-controlled infusion for induction M group – patient receiving propofol through manual controlled infusion for induction On the previous day of surgery, all the patients will have pre anaesthetic evaluation done
Patients’ parts are prepared for surgery and will be shifted to operation theatre on the day of surgery. Under all aseptic precautions 18-gauge intravenous cannula will be secured and started with maintenance iv fluids. Patient will be connected to multipara monitor inside the operation theatre. Baseline heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation and Electrocardiogram will be recorded.
Bispectral index (BIS) monitoring will be connected to all the patients. The B BRAUN system, which can deliver propofol by both manual controlled or target controlled infusion will be used for both M and T group, thus blinding the patients. The infusion machine will be covered with opaque cloth by the researcher. A second anesthetist who is collecting the data will not be present during randomisation and induction of anesthesia and he/she is also unaware of which infusion system is running. In the T group, anesthesia is induced using TCI based on Schnider pharmacokinetic model by targeting a propofol plasma concentration of 4 mcg/ml at a rate of 1200 ml/hr until induction is achieved. For the M group, Anesthesia is induced with bolus dose of propofol using B BRAUN medical infusion pump at an initial dose 2 mg/kg propofol with the same rate limitation of 1200 ml/hr.
Induction time is considered as the period between the initiation of infusion dose of the drug and when the BIS is decreased to less than 60. The dose which will be requiring for achieving induction in the both the groups will be noted.
Once this is done all parameters will be statistically analysed. |