The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • biaural beat

    Device

    Participants receive binaural beats via earphones from OR entry until end of surgery.

  • control

    Device

    Participants wear identical earphones but receive no audio stimulation.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: biaural beatExperimental treatment 1 intervention
Group B: controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total intraoperative remimazolam dose

Total amount of remimazolam administered during general anesthesia

Time frame
From induction of anesthesia to end of surgery

Secondary outcomes

1

Total intraoperative remifentanil dose

Total remifentanil administered using target-controlled infusion.

Time frame
Intraoperative period
2

BIS

BIS levels measured continuously.

Time frame
Intraoperative period
3

Postoperative analgesic use

Amount of opioids, non-opioid analgesics administered.

Time frame
PACU until Postoperative day 1
4

Heart rate

Heart rate during operation

Time frame
intraoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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