The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine

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

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-02-10

Brief Summary

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The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.

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Detailed Description

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Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.

Conditions

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Sedative Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Binaural group

Play realtime binaural sound applied music through headphones

Group Type EXPERIMENTAL

Real-time binaural sound

Intervention Type PROCEDURE

Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.

Audio group

Play music through headphones.

Group Type ACTIVE_COMPARATOR

Music

Intervention Type PROCEDURE

Play the same music in both ears through headphones during sedation

Control group

Wear headphones that do not produce sound.

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Just wear headphones during sedation

Interventions

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Real-time binaural sound

Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.

Intervention Type PROCEDURE

Music

Play the same music in both ears through headphones during sedation

Intervention Type PROCEDURE

Control

Just wear headphones during sedation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer

Exclusion Criteria

* ASA physical status classification 3-4
* Patients with hearing loss or using hearing aids
* Patients who received narcotic analgesics or sedative drugs within 1 week
* Patients with alcohol dependence or drug dependence
* Patients with drug hypersensitivity to dexmedetomidine
* Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output
* Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease
* Patients with liver failure
* Patients with kidney failure or on dialysis
* Patients judged to be unsuitable for the clinical trial by the researchers
* Patients whose actual operation time is less than 30 minutes

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No