Binaural Sound for Remimazolam Induction

November 17, 2023 updated by: Hyun-Chang Kim, Gangnam Severance Hospital

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

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.

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

Study Locations

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 generla 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
  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
Experimental: I (Binaural)
Binaural sound using headphone will be applied.
Procedure: Binaural sound
Binaural sound: Binaural sound will be applied.
Placebo Comparator: II (Placebo)
Only headphone without sound will be applied.
Procedure: Placebo
Only headphone without sound will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remimazolam dose for no response to voice
Time Frame: At anesthesia day 0
Remimazolam dose for no response to voice will be measured at anesthesia day 0.
At anesthesia day 0

Secondary Outcome Measures

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

November 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2023-0305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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