Binaural Sound for Remimazolam Maintenance
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: Binaural sound.
- Who it may be relevant to
- Registry conditions: General Anesthesia, Prostate Cancer Stage, Uterine Myoma. Basic parameters: from 20 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
- South Korea
- 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 Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial
Overview
It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.
Interventions
- Procedure Binaural sound
Binaural sound: Binaural sound will be applied.
Primary outcome measures
- Intraoperative remifentanil dose [Time frame: At anesthesia day 0]
Secondary outcome measures (3)
- Intraoperative remimazolam dose [Time frame: At anesthesia day 0]
- Pain score (0:no pain, 10:maximal pain) [Time frame: At anesthesia day 0 and 1]
- Electroencephalography [Time frame: At anesthesia day 0]
Eligibility criteria
Inclusion criteria
- Patients scheduled for general anesthesia
- Patients aged 20-60
- Patients with American Society of Anesthesiologist physical status classification 1-2
- Patients with ideal body weight 50-80 kg
Exclusion criteria
- Patients with hearing disability
- Patients using opioids or sedatives in 1 week
- Patients who are dependent for alcoholics or drugs
- Patients with hypersensitivities to remimazolam or remifentanil
- Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
- Patients with liver failure
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
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Gangnam Severance Hospital — Seoul
Identifiers
NCT: NCT06497283 · 3-2024-0171