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Not yet recruiting NCT07311642

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

No phase Interventional Breast Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biaural beat, control.
Who it may be relevant to
Registry conditions: Breast Reconstruction. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial

Overview

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.

Interventions

  • Device biaural beat
    Participants receive binaural beats via earphones from OR entry until end of surgery.
  • Device control
    Participants wear identical earphones but receive no audio stimulation.

Primary outcome measures

  • Total intraoperative remimazolam dose [Time frame: From induction of anesthesia to end of surgery]
Secondary outcome measures (7)
  • Total intraoperative remifentanil dose [Time frame: Intraoperative period]
  • BIS [Time frame: Intraoperative period]
  • Postoperative analgesic use [Time frame: PACU until Postoperative day 1]
  • Heart rate [Time frame: intraoperative]
  • blood pressure [Time frame: intraoperative]
  • SpO₂ [Time frame: intraoperative]
  • Postoperative antiemetic use [Time frame: PACU until Postoperative day 1]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.

Exclusion criteria

  • 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
  • Patients with alcohol dependence or substance abuse
  • Patients deemed inappropriate for study participation at the discretion of the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07311642 · 2510-082-1686

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗