UnknownNot Applicable

Safety and Efficacy of Remimazolam in OPCAB Surgery

South Korea94 participantsStarted 2022-06-15

Plain-language summary

Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven. In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured. Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.

Who can participate

Age range

19 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 19 years of age or older to receive OPCAB surgery * Clinical diagnosis of coronary artery obstructive disease Exclusion Criteria: * Ejection fraction \< 35% at preoperative ECHO test * Mitral regurgitation \> grade 2 at preoperative ECHO test * Currently using inotropics * Currently receiving mechanical support

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

cardiac index (T4)

Timeframe: 5 minutes before operation

cardiac index (T5)

Timeframe: 10 minutes after starting left internal mammary artery dissection

cardiac index (T6)

Timeframe: 10 minutes after starting left anterior descending coronary artery anastomosis

cardiac index (T7)

Timeframe: 10 minutes after starting Y-graft anastomosis of graft vessels

Trial details

NCT IDNCT05396690

SponsorAjou University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-30

Contact for this trial

ji young yoo

01056902104 anesyoo@aumc.ac.kr

View on ClinicalTrials.gov More Coronary Artery Bypass Surgery trials