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Binaural Sound for Remimazolam Induction

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06099977
Enrollment
72
Registered
2023-10-25
Start date
2023-11-01
Completion date
2025-10-30
Last updated
2023-11-18

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

Conditions

General Anesthesia, Prostate Cancer, Uterine Myoma

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.

Interventions

PROCEDUREBinaural sound

Binaural sound: Binaural sound will be applied.

PROCEDUREPlacebo

Only headphone without 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 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

Design outcomes

Primary

MeasureTime frameDescription
Remimazolam dose for no response to voiceAt anesthesia day 0Remimazolam dose for no response to voice will be measured at anesthesia day 0.

Secondary

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

Countries

South Korea

Contacts

Primary ContactHyun-Chang Kim
onidori@yuhs.ac82-2-2224-3919

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026