| CTRI Number |
CTRI/2021/07/034673 [Registered on: 07/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three different combinations of ketofol for induction of general anaesthesia |
|
Scientific Title of Study
|
A comparative study on three different combinations of ketofol for induction of general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bijaya Chingtham |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical sciences, Imphal |
| Address |
Department of Anesthesiology
Regional Institute of Medical Sciences, Imphal, Lamphel, Manipur 795004
Imphal West
MANIPUR
795004
India |
| Phone |
8731858652 |
| Fax |
|
| Email |
bijayachingtham1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Langpoklakpam Chaoba Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Regional Institute of Medical sciences, Imphal,lamphel, Manipur 795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Langpoklakpam Chaoba Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Regional Institute of Medical Sciences, Imphal, Lamphel, Manipur 795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional institute of medical sciences, Lamphel, Imphal, Manipur,795004 |
|
|
Primary Sponsor
|
| Name |
Bijaya Chingtham |
| Address |
Department of Anaesthesiology,Regional institute of medical sciences, Lamphel, Imphal, Manipur,795004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bijaya Chingtham |
Regional institute of medical sciences, Lamphel, Imphal |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal,Manipur, 795004
Imphal West
MANIPUR |
8731858652
bijayachingtham1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional institute of medical sciences, Imphal |
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 |
Ketofol 1:1 |
Intravenous ketamine 1mg/kg and propofol 1mg/kg diluted with normal saline till 15 ml is given till the loss of verbal command |
| Intervention |
Ketofol 1:2 |
Intravenous ketamine 0.66mg/kg and propofol 1.33mg/kg ,diluted with normal saline till 15 ml is given till the loss the verbal command |
| Intervention |
Ketofol 1:3 |
Intravenous ketamine 0.5mg/kg and propofol 1.5mg/ kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA I or II
Patients willing to give consent
Patients of age group 18 to 60 years undergoing elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusal
Anticipated difficult airway
Patients with diabetes or hypertension
Pregnant or breastfeeding mother
Patients with respiratory, cardiac ,neurological,renal or liver disease
Patients with known allergy to drugs used for induction of anesthesia
Psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction time, hemodynamic response to induction of general anesthesia, adverse outcome if ,any |
From the start of induction till loss of verbal command, hemodynamic parameters: baseline,just after induction, 1 minute, 2 minutes, 3 minutes, 4 minutes and 5 minutes after induction. adverse effects if any in post operative care unit |
|
|
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)
|
10/07/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to compare the hemodynamic response after induction of general anesthesia with different combinations of ketofol. One group will receive intravenous ketamine @ dose of 1mg/ kg and propofol @ 1mg/ kg. Another group will receive 1.33 mg/ kg of propofol and 0.66 mg/kg of ketamine. And the third group will receive 1.5 mg/ kg of propofol and 0.5mg/ kg of ketamine. Hemodynamic parameters will be recorded just after induction till 5 minutes after induction for every one minute |