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Binaural Sound Effects for General Anesthesia

NCT05431881 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-08-15

No results posted yet for this study

Summary

30 minutes before entering the operating room, the anxiety score is evaluated using a visual analogue scale (VAS) score, and stereo headphones, which can transmit binaural beat, are put on. According to a computer-generated assignment table, subjects are divided into an experimental group and a control group.

Binaural beat is applied to the experimental group for 20 minutes, and a silent state is applied to the control group for 20 minutes. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthsia are attached. Before induction of anesthesia, the anxiety score is evaluated on a VAS, again.

For anesthesia induction, propofol is administered at a rate of 10 mg every 15 seconds over 5 seconds. Assess the amount of propofol administered until the response to voice ("Open your eyes.") is absent, the subject's eyelash reflex disappears, and the PSI reaches below 50. Discontinue propofol injection when all three assessments (unresponsiveness to voice, loss of eyelash reflexes, Patient Sate Index (PSI) ≤ 50) become positive.

Conditions

  • Anesthesia, General

Interventions

PROCEDURE

Binaural beat

Different frequencies are transmitted in both ears, causing beats. The low frequency sound generated by beats induces brainwaves entrainment.

PROCEDURE

Silent

Apply a wave file which is created in silence.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jeong-Hwa Seo, MD.,PhD. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2023-09-07
Completion
2023-10-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05431881 on ClinicalTrials.gov