Binaural Sound for Remimazolam Induction

Not Applicable

Recruiting

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

• Registration Number: NCT06099977
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-30

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients scheduled for generla 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
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
II (Placebo)	Placebo	Only headphone without sound will be applied.
I (Binaural)	Binaural sound	Binaural sound using headphone will be applied.

Primary Outcome Measures

Name	Time	Method
Remimazolam dose for no response to voice	At anesthesia day 0	Remimazolam dose for no response to voice will be measured at anesthesia day 0.

Secondary Outcome Measures

Name	Time	Method
Remimazolam dose for patient state index 50	At anesthesia day 0	Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
Patient state index electroencephalography	At anesthesia day 0	Patient state index electroencephalography will be evaluated at anesthesia day 0
Anxiety level	At anesthesia day 0	Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
Remimazolam dose for no eye lash reflex	At anesthesia day 0	Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.

Trial Locations

Locations (1)

GangnamSeveranceHospital; 🇰🇷 Seoul, Korea, Republic of