| 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
|
|
|
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
|
|
|
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
|
|
|
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. |