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Trial Title:
Binaural Sound for Remimazolam Induction
NCT ID:
NCT06099977
Condition:
General Anesthesia
Prostate Cancer
Uterine Myoma
Conditions: Official terms:
Leiomyoma
Myofibroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Binaural sound
Description:
Binaural sound: Binaural sound will be applied.
Arm group label:
I (Binaural)
Intervention type:
Procedure
Intervention name:
Placebo
Description:
Only headphone without sound will be applied.
Arm group label:
II (Placebo)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GangnamSeveranceHospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
HyunChang Kim
Email:
ONIDORI@yuhs.ac
Start date:
November 1, 2023
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Gangnam Severance Hospital
Agency class:
Other
Source:
Gangnam Severance Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099977
