Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection

Since its introduction in 1973, etomidate has been widely used in clinical anaesthesia, especially in haemodynamically unstable patients, as a new anaesthetic induction drug with the advantage of low circulatory and respiratory depression. When administered via intravenous injection, etomidate can cause adverse effects such as injection pain and myoclonus. The incidence of myoclonus is still reported to be as high as 50-80%. Myoclonus caused by etomidate may cause discomfort during induction of anaesthesia and reduce perioperative satisfaction, and may lead to syringe dislodgement, extravasation of the injected drug, swelling at the injection site, delayed induction of anaesthesia and, in severe cases, cardiovascular adverse events. Therefore, the myoclonus and limb retraction reactions caused by etomidate are a key concern for clinical anaesthesiologists and need to be addressed at a time when comfort anaesthesia is being promoted. The aim of this study was to reduce myoclonus produced by etomidate injection during induction of general anaesthesia in surgical patients and to investigate the half effective dose of remifentanil to reduce etomidate myoclonus.

Study Overview

• Status: Not yet recruiting
• Conditions: Myoclonus; Etomidate
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA # or # level.

Exclusion Criteria:

• Allergy or contraindication to remifentanil or rocuronium; required for Central venipuncture catheterization;
• Abnormal liver or kidney function;
• Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
• Hearing and language impairment;
• Peripheral vascular disease;
• Severe cardiovascular disease or neurological disorders;
• Failure of one-time peripheral venipuncture;
• Infection of hand or wrist skin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age range of 18 to 40 years olds; Based on previous literature and preliminary test results, the initial dose of pre-injection remifentanil is set at 1ug / kg. The dose of remifentanil is based on the patient's degree of myoclonus. If there is no myoclonus (negative response), the dose of remifentanil is reduced for the next patient until the patient develops myoclonus. If there is myoclonus (positive response), the dose of remifentanil will be increased in the next patient until the patient is free of myoclonus.	Drug: Remifentanil; Advanced intravenous injection of remifentanil before the etomidate injection
Experimental: Age range of 41 to 55 years olds; Based on previous literature and preliminary test results, the initial dose of pre-injection remifentanil is set at 1ug / kg. The dose of remifentanil is based on the patient's degree of myoclonus. If there is no myoclonus (negative response), the dose of remifentanil is reduced for the next patient until the patient develops myoclonus. If there is myoclonus (positive response), the dose of remifentanil will be increased in the next patient until the patient is free of myoclonus.	Drug: Remifentanil; Advanced intravenous injection of remifentanil before the etomidate injection
Experimental: Age range of 56 to 70 years olds; Based on previous literature and preliminary test results, the initial dose of pre-injection remifentanil is set at 1ug / kg. The dose of remifentanil is based on the patient's degree of myoclonus. If there is no myoclonus (negative response), the dose of remifentanil is reduced for the next patient until the patient develops myoclonus. If there is myoclonus (positive response), the dose of remifentanil will be increased in the next patient until the patient is free of myoclonus.	Drug: Remifentanil; Advanced intravenous injection of remifentanil before the etomidate injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of myoclonus	Yes or No	an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
The levels of myoclonus	an average of 2 minutes

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Myoclonus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 202230217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No