About this trial
This prospective randomized controlled trial evaluates whether intraoperative binaural beats reduce the remimazolam dose required for general anesthesia in 88 adults undergoing breast surgery. Patients are assigned to binaural beats or silent earphones, and the primary outcome is total intraoperative remimazolam consumption.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.
Disqualifiers
Patients with hearing impairment, hearing loss, or those using hearing aids
Patients with external auditory canal disease that prevents wearing earphones
Patients with chronic use of hypnotics or sedatives
Patients with a history of obstructive sleep apnea or a BMI ≥ 35 kg/m²
Trial design
Parallel
Treatments tested in this trial
biaural beat
DeviceParticipants receive binaural beats via earphones from OR entry until end of surgery.
control
DeviceParticipants wear identical earphones but receive no audio stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Total intraoperative remimazolam dose
Total amount of remimazolam administered during general anesthesia
Secondary outcomes
Total intraoperative remifentanil dose
Total remifentanil administered using target-controlled infusion.
BIS
BIS levels measured continuously.
Postoperative analgesic use
Amount of opioids, non-opioid analgesics administered.
Heart rate
Heart rate during operation
Locations
Sponsors and contacts
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