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

Seoul National University

Status: Completed

Conditions: Sedative Adverse Reaction

Treatments: Procedure: Real-time binaural sound; Procedure: Control; Procedure: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT04866433

2101-185-1193

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 189 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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189 participants in 3 patient groups

Binaural group

Experimental group

Description:

Play realtime binaural sound applied music through headphones

Treatment:

Procedure: Real-time binaural sound

Audio group

Active Comparator group

Description:

Play music through headphones.

Treatment:

Procedure: Music

Control group

Sham Comparator group

Description:

Wear headphones that do not produce sound.

Treatment:

Procedure: Control