Binaural Sound for Remimazolam Induction

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099977
• Other study ID #: 3-2023-0305
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: November 2023
• Source: Gangnam Severance Hospital
• Contact: Hyun-Chang Kim
• Phone: 82-2-2224-3919
• Email: onidori[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 30, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Leiomyoma
• Prostate Cancer
• Uterine Myoma

Intervention

Procedure:
• Binaural sound
Binaural sound: Binaural sound will be applied.
• Placebo
Only headphone without sound will be applied.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeveranceHospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remimazolam dose for no response to voice	Remimazolam dose for no response to voice will be measured at anesthesia day 0.	At anesthesia day 0
Secondary	Remimazolam dose for no eye lash reflex	Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.	At anesthesia day 0
Secondary	Remimazolam dose for patient state index 50	Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.	At anesthesia day 0
Secondary	Anxiety level	Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).	At anesthesia day 0
Secondary	Patient state index electroencephalography	Patient state index electroencephalography will be evaluated at anesthesia day 0	At anesthesia day 0