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The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients

Primary Purpose

Remimazolam

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remimazolam
remifantanil
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Remimazolam

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The adult patients who are scheduled to surgery under general anesthesia

Exclusion Criteria:

  • Severe obesity (BMI > 30 kg/m2)
  • Allergy to remimazolam or remifentanil
  • Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc.
  • Patients with general conditions are more than ASA class III
  • Patients with brain disease (dementia, cerebral infarction, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    remifentanil group

    control group

    Arm Description

    Start the continuous infusion of 25cc of remifantanil (labeled as a test drug) by TCI mode ( the target effect site concentration is 2.0). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.

    Start the continuous infusion of 25cc of normal saline (labeled as a test drug). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.

    Outcomes

    Primary Outcome Measures

    Remimazolam dose at which loss of consciousness occurs
    While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.

    Secondary Outcome Measures

    Time to loss of consciousness
    After injection of remimazolam, the investigator concludes the successful loss of consciousness (not respond to oral commands and the disappearance of the eyelash reflex); From remimazolam injection until loss of consciousness occurs

    Full Information

    First Posted
    June 20, 2022
    Last Updated
    June 26, 2022
    Sponsor
    Ajou University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05434494
    Brief Title
    The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
    Official Title
    The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine

    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
    This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 [ED95]) required for loss of consciousness during anesthesia induction. .

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    remifentanil group
    Arm Type
    Active Comparator
    Arm Description
    Start the continuous infusion of 25cc of remifantanil (labeled as a test drug) by TCI mode ( the target effect site concentration is 2.0). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    Start the continuous infusion of 25cc of normal saline (labeled as a test drug). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Remimazolam
    Intervention Description
    Remimazolam is injected for 30 seconds and the experimental dose will be determined according to the biased coin design up-and-down sequential method. If loss of consciousness is successful, the dose of the next intravenous dose of the next study subject will be reduced from the previous dose with a probability of 1/19 or the same as the previous dose with a probability of 18/19.
    Intervention Type
    Drug
    Intervention Name(s)
    remifantanil
    Intervention Description
    25cc infusion drug will be prepared (labeled as test drug) and infused with TCI mode. The target effect site concentration is 2.0 ng/ml.
    Primary Outcome Measure Information:
    Title
    Remimazolam dose at which loss of consciousness occurs
    Description
    While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.
    Time Frame
    3 min after remimazolam injection
    Secondary Outcome Measure Information:
    Title
    Time to loss of consciousness
    Description
    After injection of remimazolam, the investigator concludes the successful loss of consciousness (not respond to oral commands and the disappearance of the eyelash reflex); From remimazolam injection until loss of consciousness occurs
    Time Frame
    time after injection of remimazolam to loss of conciousness

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The adult patients who are scheduled to surgery under general anesthesia Exclusion Criteria: Severe obesity (BMI > 30 kg/m2) Allergy to remimazolam or remifentanil Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc. Patients with general conditions are more than ASA class III Patients with brain disease (dementia, cerebral infarction, etc.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ji young yoo
    Phone
    01056902104
    Email
    anesyoo@aumc.ac.kr

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients

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