Binaural Sound for Remimazolam Maintenance

Not Applicable

Recruiting

• Conditions: Uterine Myoma; General Anesthesia; Prostate Cancer Stage
• Interventions: Procedure: Binaural sound

• Registration Number: NCT06497283
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-11
• Study Start: 2024-07-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I (Binaural)	Binaural sound	Binaural sound using earphone will be applied.
II (Placebo)	Binaural sound	Only headphone without sound will be applied.

Primary Outcome Measures

Name	Time	Method
Intraoperative remifentanil dose	At anesthesia day 0	Intraoperative remifentanil dose will be measured at anesthesia day 0.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of