Binaural Sound for Remimazolam Maintenance

NCT ID: NCT06497283

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2025-02-28

Brief Summary

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It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.

Detailed Description

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Conditions

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General Anesthesia Prostate Cancer Stage Uterine Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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I (Binaural)

Binaural sound using earphone will be applied.

Group Type EXPERIMENTAL

Binaural sound

Intervention Type PROCEDURE

Binaural sound: Binaural sound will be applied.

II (Placebo)

Only headphone without sound will be applied.

Group Type PLACEBO_COMPARATOR

Binaural sound

Intervention Type PROCEDURE

Binaural sound: Binaural sound will be applied.

Interventions

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Binaural sound

Binaural sound: Binaural sound will be applied.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients scheduled for general anesthesia
2. Patients aged 20-60
3. Patients with American Society of Anesthesiologist physical status classification 1-2
4. Patients with ideal body weight 50-80 kg

Exclusion Criteria

1. Patients with hearing disability
2. Patients using opioids or sedatives in 1 week
3. Patients who are dependent for alcoholics or drugs
4. Patients with hypersensitivities to remimazolam or remifentanil
5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
6. Patients with liver failure
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Chang Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun-Chang Kim

Role: CONTACT

0220194601

Facility Contacts

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Hyun Chang Kim

Role: primary

82-2-2019-4601

Other Identifiers

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3-2024-0171

Identifier Type: -

Identifier Source: org_study_id

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