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CTRI Number  CTRI/2025/07/090650 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison between Pretreatment with low dose Ketamine and low dose Propofol for reducing Jerky muscle movement caused by Etomidate as an induction agent. 
Scientific Title of Study   A Comparative Study between low dose Ketamine and low dose Propofol for the reduction of myoclonus caused by Etomidate as an induction agent. 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SADHARIYA MONA DIPAKBHAI 
Designation  RESIDENT DOCTOR ANAESTHESIOLOGY  
Affiliation  BJ MEDICAL COLLEGE AHMEDABAD  
Address  F3, TRAUMA BUILDING, FIRST FLOOR, DEPARTMENT OF ANAESTHESIA,CIVIL CAMPUS, HARIPURA, ASARWA,AHMEDABAD

Rajkot
GUJARAT
380016
India 
Phone  7984915246  
Fax    
Email  monasadhariya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  CHIRAG PATEL 
Designation  ASSOCIATE PROFESSOR, DEPARTMENT OF ANAES 
Affiliation  BJ MEDICAL COLLEGE AHMEDABAD  
Address  F3, TRAUMA BUILDING, FIRST FLOOR, DEPARTMENT OF ANAESTHESIA,CIVIL CAMPUS, HARIPURA, ASARWA,AHMEDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9898126456  
Fax    
Email  drchiragpateld10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHIRAG PATEL 
Designation  ASSOCIATE PROFESSOR, DEPARTMENT OF ANAES 
Affiliation  BJ MEDICAL COLLEGE AHMEDABAD  
Address  F3, TRAUMA BUILDING, FIRST FLOOR, DEPARTMENT OF ANAESTHESIA,CIVIL CAMPUS, HARIPURA, ASARWA,AHMEDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9898126456  
Fax    
Email  drchiragpateld10@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SADHARIYA MONA DIPAKBHAI 
Address  F3, TRAUMA BUILDING, FIRST FLOOR, DEPARTMENT OF ANAESTHESIA,CIVIL CAMPUS, HARIPURA, ASARWA,AHMEDABAD 380016 
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 SADHARIYA MONA DIPAKBHAI  1200 BED AND TRAUMA BUILDING CIVIL HOSPITAL AHMEDABAD   F3, FIRST FLOOR TRAUMA BUILDING DEPARTMENT OF ANAESTHESIOLOGY AHMEDABAD,380016
Ahmadabad
GUJARAT 
7984915246

monasadhariya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee   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 
Intervention  Pretreatment with low dose Ketamine 1 minute before induction with Etomidate   Low dose Ketamine at 0.2 mg/kg IV administered 1 minute before induction with IV Etomidate (0.3 mg/kg) and incidence of myoclonus observed within first 2-3 minutes following Etomidate administration. 
Comparator Agent  Pretreatment with low dose Propofol 1 minute before induction with Etomidate   Low dose Propofol at 0.5 mg/kg IV administered 1 minute before induction with IV Etomidate (0.3 mg/kg) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Scheduled For Elective Surgeries Requiring General Anaesthesia with ASA I and II 
 
ExclusionCriteria 
Details  Known Allergy or Contraindication to Ketamine , Propofol and Etomidate or History of Epilepsy or other Seizure Disorders or
Pregnant or Breast Feeding women or ASA III , IV and V or
Patients on chronic sedative or analgesic medication  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence and Severity of Myoclonus following Etomidate administration   Baseline, 1 min,2 min ,3 min ,5 min ,10 min, 15 min, 30 min ,45 min ,1 hr, 1hr 30 min , 2 hr,Post op Immediate,Post op 1 hr 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   31/07/2025 
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  
Etomidate is a short-acting intravenous anesthetic agent used primarily for the induction of general
anesthesia and sedation for short procedure. Etomidate works by enhancing the activity of
gamma-aminobutyric acid (GABA) at the GABA A receptors, which are inhibitory neurotransmitters
in the brain. This results in central nervous system depression and sedation. Although Etomidate is
widely preferred due to its minimal cardiovascular and respiratory stability, one of its notable side
effects is myoclonus,especially during the induction phase of anaesthesia . Etomidate
 induced myoclonus refers to involuntary,brief,jerky muscle movements that can occur after the
administration of Etomidate.

The exact cause of Etomidate induced myoclonus is not fully understood but it is thought to be related to the
disinhibition of subcortical structures that are normally suppressed by the brain, resulting in
transient,uncoordinated muscle activity.Myoclonus can lead to damage of muscle fibers, myalgia,
patient discomfort and can also be detrimental in patients with low cardiac reserve.

Etomidate induced myoclonus can be managed by premedicating with other agents like Dexmedetomidine,
Midazolam,Low dose Ketamine,Gabapentin,Dezocine,Magnesium sulfate,Opioids .Low dosePropofol and 
low dose Ketamine are two such agents that have been studied for their efficacy in reducing Etomidate-induced myoclonus. 
Here is a comparison of the two:Propofol is a sedative-hypnotic agent that works by enhancing GABA A receptor activity, 
leading to increased inhibitory neurotransmission and Ketamine is an NMDA receptor antagonist that provides analgesia 
and sedation by blocking excitatory neurotransmission . Therefore our aim for this study is to conpare the low dose 
Ketamine and low dose Propofol for the reduction of myoclonus caused by Etomidate as an induction agent.
 
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