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

Primary Purpose

Etomidate, Myoclonus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Etomidate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages ranged from 18 to 80. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Age range of 18 to 40 years olds

    Age range of 41 to 55 years olds

    Age range of 56 to 70 years olds

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    The presence of myoclonus
    Yes or No

    Secondary Outcome Measures

    The levels of myoclonus

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    March 3, 2023
    Sponsor
    Yangzhou University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05754762
    Brief Title
    Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection
    Official Title
    Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yangzhou University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Etomidate, Myoclonus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Age range of 18 to 40 years olds
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Age range of 41 to 55 years olds
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Age range of 56 to 70 years olds
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    Advanced intravenous injection of remifentanil before the etomidate injection
    Primary Outcome Measure Information:
    Title
    The presence of myoclonus
    Description
    Yes or No
    Time Frame
    an average of 2 minutes
    Secondary Outcome Measure Information:
    Title
    The levels of myoclonus
    Time Frame
    an average of 2 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ages ranged from 18 to 80. 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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