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Binaural Sound for Remimazolam Induction

Primary Purpose

General Anesthesia, Prostate Cancer, Uterine Myoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Binaural sound
Placebo
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Anesthesia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled for generla anesthesia Patients aged 20-60 Patients with American Society of Anesthesiologist physical status classification 1-2 Patients with ideal body weight 50-80 kg Exclusion Criteria: Patients with hearing disability Patients using opioids or sedatives in 1 week Patients who are dependent for alcoholics or drugs Patients with hypersensitivities to remimazolam Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia Patients with liver failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    I (Binaural)

    II (Placebo)

    Arm Description

    Binaural sound using headphone will be applied.

    Only headphone without sound will be applied.

    Outcomes

    Primary Outcome Measures

    Remimazolam dose for no response to voice
    Remimazolam dose for no response to voice will be measured at anesthesia day 0.

    Secondary Outcome Measures

    Remimazolam dose for no eye lash reflex
    Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.
    Remimazolam dose for patient state index 50
    Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
    Anxiety level
    Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
    Patient state index electroencephalography
    Patient state index electroencephalography will be evaluated at anesthesia day 0

    Full Information

    First Posted
    October 20, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099977
    Brief Title
    Binaural Sound for Remimazolam Induction
    Official Title
    The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    October 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    General Anesthesia, Prostate Cancer, Uterine Myoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    I (Binaural)
    Arm Type
    Experimental
    Arm Description
    Binaural sound using headphone will be applied.
    Arm Title
    II (Placebo)
    Arm Type
    Placebo Comparator
    Arm Description
    Only headphone without sound will be applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    Binaural sound
    Intervention Description
    Binaural sound: Binaural sound will be applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo
    Intervention Description
    Only headphone without sound will be applied.
    Primary Outcome Measure Information:
    Title
    Remimazolam dose for no response to voice
    Description
    Remimazolam dose for no response to voice will be measured at anesthesia day 0.
    Time Frame
    At anesthesia day 0
    Secondary Outcome Measure Information:
    Title
    Remimazolam dose for no eye lash reflex
    Description
    Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.
    Time Frame
    At anesthesia day 0
    Title
    Remimazolam dose for patient state index 50
    Description
    Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
    Time Frame
    At anesthesia day 0
    Title
    Anxiety level
    Description
    Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
    Time Frame
    At anesthesia day 0
    Title
    Patient state index electroencephalography
    Description
    Patient state index electroencephalography will be evaluated at anesthesia day 0
    Time Frame
    At anesthesia day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for generla anesthesia Patients aged 20-60 Patients with American Society of Anesthesiologist physical status classification 1-2 Patients with ideal body weight 50-80 kg Exclusion Criteria: Patients with hearing disability Patients using opioids or sedatives in 1 week Patients who are dependent for alcoholics or drugs Patients with hypersensitivities to remimazolam Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia Patients with liver failure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyun-Chang Kim
    Phone
    82-2-2224-3919
    Email
    onidori@yuhs.ac

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Binaural Sound for Remimazolam Induction

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