Clinical trial NCT04866433: The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine
Official title: The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedative Adverse Reaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 189
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
timeFrame: Intraoperative (During sedation for surgery)
Secondary outcomes:
measure: Observer's Assessment of Alertness/Sedation Scale (0~5)
timeFrame: During sedation for surgery and at post anesthesia care unit (PACU)
measure: Patient State Index (PSi)
timeFrame: Intraoperative (During sedation for surgery)
measure: Dexmedetomidine continuous infusion dose
timeFrame: Intraoperative (During sedation for surgery)
measure: Number of patients requiring additional sedatives
timeFrame: Intraoperative (During sedation for surgery)
measure: Adverse event
timeFrame: Intraoperative (During sedation for surgery)
measure: Patient satisfaction
timeFrame: Intraoperative (At the time of leaving the operating room)
measure: Postanesthesia recovery score (0~10)
timeFrame: At the postanesthesia recovery room
measure: Postoperative delirium
timeFrame: From the end of the surgery to the hospital discharge, an average of 1 week
Other outcomes:
measure: EEG power in delta band
timeFrame: During sedation for surgery
measure: EEG power in theta band
timeFrame: During sedation for surgery
measure: EEG power in alpha band
timeFrame: During sedation for surgery
measure: EEG power in beta band
timeFrame: During sedation for surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: