Comparison of three ways of etomidate injection, a general anaesthetic drug to decrease muscle movement caused by etomidate.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/03/032459
• Lead Sponsor: M S Ramaiah Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Patients with ASA physical status I and II, requiring general anaesthesia for elective surgery.

Exclusion Criteria

• Pre-existing adrenal disease / adrenocortical insufficiency 2.
• Receiving / History of receiving steroids within the last 3 months 3.
• Seizure disorder 5.
• Hypersensitivity to Etomidate 6.
• Patients undergoing Emergency surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To compare in all the groups	i) The grade of pain on injection

Trial Locations

Locations (1)

Department of Anaesthesiology; 🇮🇳 Bangalore, KARNATAKA, India

Department of Anaesthesiology

🇮🇳Bangalore, KARNATAKA, India

Dr Ridhi Rao

Principal investigator

9900086577

ridhirao@gmail.com