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

NCT05754762 — Not applicable, Unknown, 70 participants, Yangzhou University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05754762
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	70 (Estimated)
Sponsor	Yangzhou University (Other)
Conditions	Etomidate, Myoclonus
Interventions	Remifentanil (Drug)
Dates	start 2023-03-01 (estimated), primary completion 2023-07-01 (estimated), completion 2023-07-01 (estimated), first posted 2023-03-06, last updated 2023-03-06

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Age range of 18 to 40 years olds	Experimental	Drug: Remifentanil	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.
Age range of 41 to 55 years olds	Experimental	Drug: Remifentanil	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.
Age range of 56 to 70 years olds	Experimental	Drug: Remifentanil	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.

Remifentanil (Drug): Advanced intravenous injection of remifentanil before the etomidate injection

+Outcome measures

Primary outcomes

The presence of myoclonus [an average of 2 minutes]: Yes or No

Secondary outcomes

The levels of myoclonus [an average of 2 minutes]

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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.