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

NCT05754762 | Unknown

• 1 other identifier: 202230217
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Etomidate; Myoclonus

Outcome Measures

Primary Outcomes (1)

• The presence of myoclonus

  Yes or No

  an average of 2 minutes

Secondary Outcomes (1)

• The levels of myoclonus

  an average of 2 minutes

Study Arms (3)

Age range of 18 to 40 years olds

EXPERIMENTAL

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

Age range of 41 to 55 years olds

EXPERIMENTAL

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

Age range of 56 to 70 years olds

EXPERIMENTAL

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

Interventions

Remifentanil DRUG

Advanced intravenous injection of remifentanil before the etomidate injection

Age range of 18 to 40 years olds; Age range of 41 to 55 years olds; Age range of 56 to 70 years olds

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages ranged from 18 to 80.
• ASA # or # level.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

MeSH Terms

Conditions

Myoclonus

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 6, 2023
• Study Start: March 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03