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CTRI Number  CTRI/2020/06/025990 [Registered on: 19/06/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two different dose-combinations of Propofol(Induction agent)and Ketamine(Induction agent)(Ketofol) as induction agent for patients undergoing surgery under general anaesthesia. 
Scientific Title of Study   A Comparative study of two different dose-combinations of Propofol and Ketamine (Ketofol) as induction agent 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Sivakumar 
Designation  Professor and Head of the department 
Affiliation  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology Government Mohan Kumaramangalam Medical College and Hospital Salem Tamilnadu

Salem
TAMIL NADU
636001
India 
Phone  9791843145  
Fax    
Email  gskp1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Arunachalam 
Designation  Associate Professor 
Affiliation  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology Government Mohan Kumaramangalam Medical College and Hospital Salem Tamilnadu

Salem
TAMIL NADU
636001
India 
Phone  9965520752  
Fax    
Email  drrarunc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Manjeth kumar 
Designation  Junior Resident 
Affiliation  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology Government Mohan Kumaramangalam Medical College and Hospital Salem Tamilnadu

Salem
TAMIL NADU
636001
India 
Phone  9500927199  
Fax    
Email  manjeth@gmail.com  
 
Source of Monetary or Material Support  
Government Mohan Kumaramangalam Medical College and Hospital, Salem, Tamilnadu 636001 
 
Primary Sponsor  
Name  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology Government Mohan Kumaramangalam Medical College and Hospital Salem Tamilnadu - 636001 
Type of Sponsor  Government 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 G Manjeth kumar  Government Mohan Kumaramangalam Medical College and Hospital  Department of Anaesthesiology
Salem
TAMIL NADU 		 9500927199

manjeth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Government mohan Kumaramangalam medical college and hospital Salem   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Propofol with Ketamine (Ketofol)  Propofol 1mg/kg+ Ketamine 1mg/kg, Propofol 1.5mg/kg+ Ketamine 0.5mg/kg Intravenous induction dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists- Physical status 1 and 2
Patients undergoing elective surgical procedure requiring Endotracheal intubation 
 
ExclusionCriteria 
Details  History of Cardiovascular of neurological disease
Pregnancy
Psychiatric disorders
Contraindication or allergies to propofol or ketamine
Emergency surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
BIS values at various intervals
Time for loss of verbal contact
Time for loss of eye lash reflex 		 Eleven time points: Time 1, BIS at baseline; Time 2, Time at loss of verbal contact; Time 3, BIS at 5 seconds after loss of verbal contact; Time 4, Time at loss of eye lash reflex; Time 5, BIS at 5 seconds after loss of eyelash reflex; Time 6, BIS at 2 minutes after induction; Time 7, BIS before intubation; Time 8,BIS after intubation; Time 9, BIS at 5 minutes; Time 10, BIS at 10 minutes; Time 11, BIS at 20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Systolic Blood Pressure
Diastolic Blood Pressure
Mean Arterial Pressure 		 Baseline
After Induction
After Intubation
5 minutes
10 minutes
20 minutes 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/06/2020 
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="2"
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)?  

Brief Summary   Patients under going elective surgical procedure under general anaesthesia will be divided into two groups. Group A will be induced with Propofol 1.5 milligrams per kilogram with Ketamine 0.5 milligrams per kilogram and Group B with Propofol 1 milligram per kilogram with Ketamine 1 milligram per kilogram. The primary observation will be BIS values at various intervals, Time to loss of verbal contact and Time to loss of eye lash reflex. The secondary observation will be Hemodynamic parameters like Systolic blood pressure, Diastolic blood pressure, Mean arterial blood pressure and Heart rate. 
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