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

Sedative Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866433
• Other study ID #: 2101-185-1193
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: February 10, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedative Adverse Reaction

Intervention

Procedure:
• Real-time binaural sound
Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.
• Music
Play the same music in both ears through headphones during sedation
• Control
Just wear headphones during sedation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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)
Secondary	Patient State Index (PSi)	Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)	Intraoperative (During sedation for surgery)
Secondary	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)
Secondary	Number of patients requiring additional sedatives	Number of patients requiring additional sedatives	Intraoperative (During sedation for surgery)
Secondary	Adverse event	Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation	Intraoperative (During sedation for surgery)
Secondary	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)
Secondary	Postanesthesia recovery score (0~10)	Postanesthesia recovery score (0~10, higher scores mean better recovery)	At the postanesthesia recovery room
Secondary	Postoperative delirium	Incidence of postoperative delirium	From the end of the surgery to the hospital discharge, an average of 1 week