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Trial Title:
Binaural Sound for Remimazolam Maintenance
NCT ID:
NCT06497283
Condition:
General Anesthesia
Prostate Cancer Stage
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)
Arm group label:
II (Placebo)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyun Chang Kim
Phone:
82-2-2019-4601
Start date:
July 12, 2024
Completion date:
February 28, 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/NCT06497283
