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

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

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.

Study Overview

• Status: Completed
• Conditions: Sedative Adverse Reaction
• Intervention / Treatment: Procedure: Real-time binaural sound; Procedure: Music; Procedure: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG power in delta band	EEG power in delta band (0.3~4Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)	During sedation for surgery
EEG power in theta band	EEG power in theta band (4~8Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)	During sedation for surgery
EEG power in alpha band	EEG power in alpha band (8~13Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)	During sedation for surgery
EEG power in beta band	EEG power in beta band (13~30Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)	During sedation for surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2101-185-1193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No