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

Myoclonus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05754762
• Other study ID #: 202230217
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2023
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Etomidate
• Myoclonus

Intervention

Drug:
• Remifentanil
Advanced intravenous injection of remifentanil before the etomidate injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of myoclonus	Yes or No	an average of 2 minutes
Secondary	The levels of myoclonus		an average of 2 minutes