| CTRI Number |
CTRI/2020/09/027965 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
18/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Dexmedetomidine for prevention of Etomidate induced Myoclonus. |
|
Scientific Title of Study
|
To study comparative efficacy with three different doses of dexmeditomidine for prevention of etomidate induced myoclonus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Kundra |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana. |
| Address |
Department of Anesthesia,
Room No 100, First floor, Adjoining NOOT Complex, Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
305-E, Shaheed Bhagat Singh Nagar, Near Indoor Stadium, Pakhowal Road, Ludhiana.
Ludhiana
PUNJAB
141013
India |
| Phone |
09815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep kundra |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana. |
| Address |
Department of Anesthesia,
Room no 100, Adjoining NOOT Complex, First Floor,
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
305-E, Shaheed Bhagat Singh Nagar, Near Indoor Stadium, Pakhowal Road,
Ludhiana.
Ludhiana
PUNJAB
141013
India |
| Phone |
09815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Jindal |
| Designation |
PG student |
| Affiliation |
Department of Anaesthesia,Dmch Ludhiana |
| Address |
Department of Anesthesia,
Room no 100,
First Floor,
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9463895362 |
| Fax |
|
| Email |
richajindal.1694@gmail.com |
|
|
Source of Monetary or Material Support
|
| Managing Society, Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana. |
|
|
Primary Sponsor
|
| Name |
Managing Society Dayanand Medical College and Hospital Tagore Nagar Ludhiana |
| Address |
Department of Anesthesia , Dayanand Medical College and hospital, Ludhiana. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Managing Society Dayanand Medical College and Hospital Tagore Nagar Ludhiana |
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandeep Kundra |
Dayanand Medical College and Hospital |
Department of Anesthesia,Room no 100, Adjoining NOOT Complex, Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
Ludhiana
PUNJAB |
9815608241
sandeepkundra07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH & ETHICAL COMMITTEE, DMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To Compare Effect Of Three Different Doses Of Dexmedetomidine (0.25ug/kg, 0.5ug/kg, 1ug/kg) over 10 mins On Etomidate (0.3mg/kg) Induced Myoclonus for 60 mins |
Elective Cases For Surgery Under General Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I OR II with BMI <30 Kg/m2 and scheduled for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
. Patients with BMI >30 kg/m2
. Patients with Bradycardia (HR<60/min),Having
Heart Blocks, on Beta Blockers or Having
Impanted Pacemakers
. Known Case of Hypoadrenalism or Patients on
Steroid medication
. H/o Asthma , Chronic Cough or Upper
Respiratory Tract Infection Two weeks Prior
to Surgery
. H/o any Neurological disease.
. H/o any Psychiatric disease.
. Pregnant and Lactating Patients.
. H/o any Drug Allergy.
. Patients having Uncontrolled Diabetes or
Hypertension.
. Patients who have received Benzodiazipines or
Opioids within the previous 24 hrs.
. Any evidence of Sepsis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Following Parameters will be statistically analysed:
1)Incidence of Etomidate
Induced Myoclonus.
2)Grading of Etomidate
Induced Myoclonus.
3)Incidence of Any Adverse
Effects. |
Study drug will be administered over 10 minutes as per group allocation.Once infusion is completed, this time will be labelled as 0 and 0.3mg/Kg Etomidate will be given I/V. Patients will be obeserved for Myoclonus for 2 minutes. Hemodynamics will be recorded every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find minimum effective dose of etomidate to suppress myoclonus |
2 minute after induction |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/09/2020 |
| 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="1"
Months="6"
Days="1" |
|
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 Prospective, Randomized, Double Blinded study will be conducted on 120 ASA I or II patients of age 18-60 years, posted for elective surgery under General Anesthesia in the Department of Anesthesia, DMCH, Ludhiana after ethical committee clearance. Patients will be randomly allocated to either of four groups as per computer generated random numbers. Group A will be given 10 ML of isotonic saline, whereas, Groups B, C, D will be administered Dexmedetomidine in a dose of 0.25 mcg/kg,0.5 mcg/kg and 1mcg/kg respectively in 10 ml of isotonic saline over 10 minutes .Once infusion is over, this time will be labelled as 0 and 0.3 mg/kg Etomidate will be given intravenously over 30 seconds. Patients will be observed for Myoclonus for 2 minutes which will be graded accordingly. Heart Rate, Blood Pressure, Hemoglobin saturation will be recorded after every 1 minute for initial 10 minutes and then every 5 minutes till end of 60 minutes. Incidence of adverse effects ( Hypotension , Bradycardia, Tachycardia, Hypertension) will be recorded.Results will be tabulated and statistically analysed. |