Binaural Sound for Remimazolam Maintenance

August 7, 2024 updated by: Hyun-Chang Kim, Gangnam Severance Hospital

The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hyun-Chang Kim
  • Phone Number: 0220194601
  • Email: gsirb@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Hyun Chang Kim
          • Phone Number: 82-2-2019-4601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: II (Placebo)
Only headphone without sound will be applied.
Procedure: Binaural sound
Binaural sound: Binaural sound will be applied.
Experimental: I (Binaural)
Binaural sound using earphone will be applied.
Procedure: Binaural sound
Binaural sound: Binaural sound will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil dose
Time Frame: At anesthesia day 0
Intraoperative remifentanil dose will be measured at anesthesia day 0.
At anesthesia day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remimazolam dose
Time Frame: At anesthesia day 0
Intraoperative remimazolam dose will be measured at anesthesia day 0.
At anesthesia day 0
Pain score (0:no pain, 10:maximal pain)
Time Frame: At anesthesia day 0 and 1
Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1.
At anesthesia day 0 and 1
Electroencephalography
Time Frame: At anesthesia day 0
The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0.
At anesthesia day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2024-0171

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on General Anesthesia

Clinical Trials on Binaural sound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe