ClinicalTrials.gg
Status unknownNCT05754762Updated Mar 6, 2023

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

An interventional study of Remifentanil in Etomidate and Myoclonus, sponsored by Yangzhou University. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Yangzhou University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Etomidate
  • Myoclonus

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03

In context

Myoclonus

20 studies on the registry are indexed under Myoclonus; 6 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 11 interventional studies indexed under Myoclonus.

Browse Myoclonus studies →

Lead sponsor

Yangzhou University is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy or 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Advanced intravenous injection of remifentanil before the etomidate injection

06

What researchers measure

Primary outcomes

  1. The presence of myoclonus

    Yes or No

    Time frame: an average of 2 minutes

Secondary outcomes

  1. The levels of myoclonus

    Time frame: an average of 2 minutes

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2023; primary completion for Jul 2023, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2023
First posted
Mar 6, 2023
StartEst.
Mar 1, 2023
Primary completionEst.
Jul 1, 2023
CompletionEst.
Jul 1, 2023
Last update
Mar 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05754762
Lead sponsor
Yangzhou University
Responsible party
Zhuan Zhang (Director, Yangzhou University) — Principal investigator
First posted
Mar 6, 2023
Start date
Mar 1, 2023 (estimated)
Primary completion
Jul 1, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Mar 6, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Remifentanil

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