CTRI Number |
CTRI/2021/03/032459 [Registered on: 31/03/2021] Trial Registered Prospectively |
Last Modified On: |
30/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia Preventive |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of three ways of etomidate injection, a general anaesthetic drug to decrease muscle movement caused by etomidate. |
Scientific Title of Study
|
Comparison of three techniques of etomidate administration for decreasing etomidate induced myoclonus: A randomized controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ridhi Rao |
Designation |
PG resident, Department of Anaesthesiology |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology, M S Ramaiah Medical College, new BEL road, M S Ramaiah Nagar,MSRIT post, Bangalore Bangalore KARNATAKA 560054 India |
Phone |
9900086577 |
Fax |
|
Email |
ridhirao@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Geetha CR |
Designation |
Professor and Head of Department of Anaesthesiology |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology, M S Ramaiah Medical College, new BEL road, M S Ramaiah Nagar,MSRIT post, Bangalore
Bangalore KARNATAKA 560054 India |
Phone |
9900482828 |
Fax |
|
Email |
jageedha@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Geetha CR |
Designation |
Professor and Head of Department of Anaesthesiology |
Affiliation |
M S Ramaiah Medical College |
Address |
Department of Anaesthesiology, M S Ramaiah Medical College, new BEL road, M S Ramaiah Nagar,MSRIT post, Bangalore
Bangalore KARNATAKA 560054 India |
Phone |
9900482828 |
Fax |
|
Email |
jageedha@yahoo.com |
|
Source of Monetary or Material Support
|
M S Ramaiah Medical College, Bangalore |
|
Primary Sponsor
|
Name |
M S Ramaiah Medical College |
Address |
new BEL road, M S Ramaiah Nagar, MSRIT post, Bangalore-560054 |
Type of Sponsor |
Private medical college |
|
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 Ridhi Rao |
Department of Anaesthesiology |
2nd floor, OT complex, Department of Anaesthesiology, M S Ramaiah Medical College hospital, new BEL road, M S Ramaiah Nagar, MSRIT post, Bangalore-560054 Bangalore KARNATAKA |
9900086577
ridhirao@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
M S Ramaiah Medical College and hospitals |
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 |
control group (Group C) |
Group C: will receive Etomidate induction dose of 0.3 mg/kg etomidate, injected manually over 20 s.
|
Comparator Agent |
priming group (Group P) |
Group P: will receive a priming dose of 0.03 mg/kg etomidate, followed after 1 min by an induction dose of 0.3 mg/kg, injected over 20 seconds.
|
Comparator Agent |
priming with slow injection group (Group B) |
Group B: will receive a priming dose of 0.03 mg/kg etomidate, followed after 1 min by an induction dose of 0.3 mg/kg, slowly injected over 2 min with a syringe pump.
|
Comparator Agent |
slow injection group (Group S) |
Group S: will receive an induction dose of 0.3 mg/kg etomidate, slowly injected over 2 min with a syringe pump
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with ASA physical status I and II, requiring general anaesthesia for elective surgery |
|
ExclusionCriteria |
Details |
1. Pre-existing adrenal disease / adrenocortical insufficiency
2. Receiving / History of receiving steroids within the last 3 months
3. Sepsis
4. Seizure disorder
5. Hypersensitivity to Etomidate
6. Patients undergoing Emergency surgery |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To compare the efficacy of priming dose technique, slow injection of induction dose technique and a combination of priming with slow injection technique in preventing etomidate induced myoclonus. |
Time of onset of myoclonus from induction and duration of myoclonus. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare in all the groups
i) The grade of pain on injection
ii) The effect on haemodynamic parameters of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and peripheral oxygen saturation. |
0 min, induction, 1 min, 2 min, 3 min, 4 min, 5 min, 6 min, intubation, 1 min post intubation, 2 min post intubation, 5 min post intubation |
|
Target Sample Size
|
Total Sample Size="296" Sample Size from India="296"
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)
|
01/04/2021 |
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="1" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By Personal Email communication
- For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Etomidate is a carboxylated nonbarbiturate imidazole derivative and is a popular intravenous anaesthetic agent due to its advantageous pharmacological profile. It has rapid onset of action and clearance, cardio-stable with minimal respiratory side effects, marginal histamine release and cerebral protective effect. However, adrenocortical suppression, myoclonus and pain on injection are adverse effects of Etomidate, Adrenocortical suppression that may occur is transient. Etomidate is contraindicated in patients with adrenal insufficiency. Myoclonus is defined as sudden, brief, involuntary muscle jerks either irregular or rhythmic, usually lasting 10-50 ms. In non premedicated patients, the incidence of myoclonus is as high as 50-80%. Myoclonus may lead to regurgitation and aspiration in patients with inadequate fasting, raised intraocular pressure in open-globe injuries with a risk of vitreal prolapse and increased myocardial oxygen consumption. Preventing the occurence of myoclonus is important as Etomidate is the preferred induction agent in hemodynamically unstable patients. A large number of drugs have been studied for their ability to prevent these myoclonic movements. However, these drugs may be associated with side effects like excessive sedation, respiratory suppression and delayed recovery. It is possible to eliminate the need for an additional drug, its inherent cost or potential side effects by changong the techniques of Etomidate injection. Pre-treatment with a low dose of Etomidate (priming dose) and slow injection of the induction dose have both been shown to reduce the incidence of Etomidate induced myoclonus (EIM). To the best of our knowledge, there are no studies comparing the efficacy of priming dose technique, induction dose given by slow injection technique and a combination of priming dose with slow injection technique in preventing EIM, Therefore, we are conducting this study to determine the efficacy of these techniques in reducing EIM, as the primary outcome. We also aim to study the efficacy of the three techniques on prevention of pain with administration of Etomidate and the effect on hemodynamic parameters of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and peripheral oxygen saturation. |