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

Study Overview
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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.

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.

Official Title
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The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial

Conditions
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Sedative Adverse Reaction

Intervention / Treatment
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* Procedure: Real-time binaural sound
* Procedure: Music
* Procedure: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binaural group<br>Play realtime binaural sound applied music through headphones | Procedure: Real-time binaural sound<br>* Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.<br>|
| Active Comparator: Audio group<br>Play music through headphones. | Procedure: Music<br>* Play the same music in both ears through headphones during sedation<br>|
| Sham Comparator: Control group<br>Wear headphones that do not produce sound. | Procedure: Control<br>* Just wear headphones during sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg) | Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg) | Intraoperative (During sedation for surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer's Assessment of Alertness/Sedation Scale (0 5) | Observer's Assessment of Alertness/Sedation Scale (0, does not respond to painful trapezius squeeze; 1, responds only after painful trapezius squeeze; 2, responds only after mild prodding or shaking; 3, responds only after name is called loudly, repeatedly, or both; 4, responds lethargically to name spoken in normal tone; 5, responds readily to name spoken in normal tone) | During sedation for surgery and at post anesthesia care unit (PACU) | 
| Patient State Index (PSi) | Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA) | Intraoperative (During sedation for surgery) | 
| Dexmedetomidine continuous infusion dose | Total amount of dexmedetomidine infused from the end of dexmedetomidine loading to the start of suturing the surgical site | Intraoperative (During sedation for surgery) | 
| Number of patients requiring additional sedatives | Number of patients requiring additional sedatives | Intraoperative (During sedation for surgery) | 
| Adverse event | Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation | Intraoperative (During sedation for surgery) | 
| Patient satisfaction | Patient's satisfaction with intraoperative sedation Score from 0 to 10) with intraoperative sedation measured at the time of leaving the operating room (0 10) | Intraoperative (At the time of leaving the operating room) | 
| Postanesthesia recovery score (0 10) | Postanesthesia recovery score (0 10, higher scores mean better recovery) | At the postanesthesia recovery room | 
| Postoperative delirium | Incidence of postoperative delirium | From the end of the surgery to the hospital discharge, an average of 1 week |