Actively Recruiting
The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial
Led by Gangnam Severance Hospital · Updated on 2024-08-09
72
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how binaural sound affects the dose of remifentanil needed during general anesthesia maintained with remimazolam. The study explores whether using binaural sound can reduce the amount of remifentanil required, improving anesthesia management. This randomized, placebo-controlled trial is sponsored by Gangnam Severance Hospital and includes adults aged 20 to 60 undergoing general anesthesia. Participants will be randomly assigned to one of two groups. One group will receive binaural sound through earphones during anesthesia, while the other group will wear headphones without sound as a placebo. The study focuses on the effects of these interventions during anesthesia on remifentanil dosage. During the anesthesia day, researchers will measure the amount of remifentanil given, monitor remimazolam dosing, and assess pain levels using a pain score from 0 to 10. Electroencephalography will also be conducted to evaluate brain activity. The study includes close monitoring to understand the impact of binaural sound on anesthesia management and patient comfort.
CONDITIONS
Brief Title
Binaural Sound for Remimazolam Maintenance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for general anesthesia
- Patients aged 20 to 60 years
- Patients with American Society of Anesthesiologist physical status classification 1 or 2
- Patients with ideal body weight between 50 and 80 kg
You will not qualify if you...
- Patients with hearing disability
- Patients who used opioids or sedatives within 1 week
- Patients dependent on alcohol or drugs
- Patients with hypersensitivity to remimazolam or remifentanil
- Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
- Patients with liver failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0 (anesthesia day)
Participants receive general anesthesia during which binaural sound or placebo is applied to assess its effect on remifentanil dose required.
1 visit (in-person) during anesthesia day
Trial Site Locations
Total: 1 location
1
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyun-Chang Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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