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

Not Applicable

Completed

• Conditions: Sedative Adverse Reaction
• Interventions: Procedure: Real-time binaural sound; Procedure: Music; Procedure: Control

• Registration Number: NCT04866433
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2021-06-01
• Primary Completion: 2022-01-27
• Status Verified: 2022-02
• Study Completion: 2022-02-10
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Binaural group	Real-time binaural sound	Play realtime binaural sound applied music through headphones
Audio group	Music	Play music through headphones.
Control group	Control	Wear headphones that do not produce sound.

Primary Outcome Measures

Name	Time	Method
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)	Intraoperative (During sedation for surgery)	Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

Secondary Outcome Measures

Name	Time	Method
Postanesthesia recovery score (0~10)	At the postanesthesia recovery room	Postanesthesia recovery score (0\~10, higher scores mean better recovery)
Observer's Assessment of Alertness/Sedation Scale (0~5)	During sedation for surgery and at post anesthesia care unit (PACU)	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)
Dexmedetomidine continuous infusion dose	Intraoperative (During sedation for surgery)	Total amount of dexmedetomidine infused from the end of dexmedetomidine loading to the start of suturing the surgical site
Adverse event	Intraoperative (During sedation for surgery)	Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation
Postoperative delirium	From the end of the surgery to the hospital discharge, an average of 1 week	Incidence of postoperative delirium
Patient State Index (PSi)	Intraoperative (During sedation for surgery)	Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)
Number of patients requiring additional sedatives	Intraoperative (During sedation for surgery)	Number of patients requiring additional sedatives
Patient satisfaction	Intraoperative (At the time of leaving the operating room)	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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of