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Binaural Sound for Remimazolam Maintenance

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06497283
Enrollment
72
Registered
2024-07-11
Start date
2024-07-12
Completion date
2025-02-28
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Prostate Cancer Stage, Uterine Myoma

Brief summary

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

Binaural sound: Binaural sound will be applied.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients scheduled for general anesthesia 2. Patients aged 20-60 3. Patients with American Society of Anesthesiologist physical status classification 1-2 4. Patients with ideal body weight 50-80 kg

Exclusion criteria

1. Patients with hearing disability 2. Patients using opioids or sedatives in 1 week 3. Patients who are dependent for alcoholics or drugs 4. Patients with hypersensitivities to remimazolam or remifentanil 5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia 6. Patients with liver failure

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative remifentanil doseAt anesthesia day 0Intraoperative remifentanil dose will be measured at anesthesia day 0.

Secondary

MeasureTime frameDescription
Intraoperative remimazolam doseAt anesthesia day 0Intraoperative remimazolam dose will be measured at anesthesia day 0.
Pain score (0:no pain, 10:maximal pain)At anesthesia day 0 and 1Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1.
ElectroencephalographyAt anesthesia day 0The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0.

Countries

South Korea

Contacts

Primary ContactHyun-Chang Kim
gsirb@yuhs.ac0220194601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026