Binaural Sound for Remimazolam Maintenance

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Uterine Myoma; Prostate Cancer Stage; General Anesthesia

Treatments: Procedure: Binaural sound

Study type: Interventional

Funder types: Other

Identifiers

NCT06497283

3-2024-0171

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

I (Binaural)

Experimental group

Description:

Binaural sound using earphone will be applied.

Treatment:

Procedure: Binaural sound

II (Placebo)

Placebo Comparator group

Description:

Only headphone without sound will be applied.

Treatment:

Procedure: Binaural sound