CompletedNot Applicable

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine

South Korea189 participantsStarted 2021-06-01

Plain-language summary

The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.

Who can participate

Age range

19 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer Exclusion Criteria: * ASA physical status classification 3-4 * Patients with hearing loss or using hearing aids * Patients who received narcotic analgesics or sedative drugs within 1 week * Patients with alcohol dependence or drug dependence * Patients with drug hypersensitivity to dexmedetomidine * Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output * Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease * Patients with liver failure * Patients with kidney failure or on dialysis * Patients judged to be unsuitable for the clinical trial by the researchers * Patients whose actual operation time is less than 30 minutes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

Timeframe: Intraoperative (During sedation for surgery)

Trial details

NCT IDNCT04866433

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-27

View on ClinicalTrials.gov More Sedative Adverse Reaction trials

Who can participate

Age range

19 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.