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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
189
Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.
Play the same music in both ears through headphones during sedation
Just wear headphones during sedation
Seoul National University Hospital
Seoul, South Korea
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
Time frame: Intraoperative (During sedation for surgery)
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)
Time frame: 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)
Time frame: 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
Time frame: Intraoperative (During sedation for surgery)
Number of patients requiring additional sedatives
Number of patients requiring additional sedatives
Time frame: Intraoperative (During sedation for surgery)
Adverse event
Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation
Time frame: Intraoperative (During sedation for surgery)
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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)
Time frame: Intraoperative (At the time of leaving the operating room)
Postanesthesia recovery score (0~10)
Postanesthesia recovery score (0\~10, higher scores mean better recovery)
Time frame: At the postanesthesia recovery room
Postoperative delirium
Incidence of postoperative delirium
Time frame: From the end of the surgery to the hospital discharge, an average of 1 week