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

• Sponsor: Yangzhou University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05754762
• Collaborator: (none)
• Enrollment: 70
• Arms: 3
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Etomidate; Myoclonus	Drug: Remifentanil	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The presence of myoclonus [an average of 2 minutes]

   Yes or No

Secondary Outcome Measures

1. The levels of myoclonus [an average of 2 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Director, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05754762
• Other Study ID Numbers: 202230217
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 6, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myoclonus; Remifentanil

Study Results

No Results Posted as of Mar 6, 2023