Using Remimazolam to Reduce Postoperative Atrial Fibrillation in Heart Surgery
The Effect of Remimazolam on Postoperative New-onset Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting
This study is testing if a new sedative called remimazolam can help prevent heart rhythm problems after heart surgery in patients having bypass surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | Yangzhou University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Trial ID | NCT05891145 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of remimazolam, a newly approved sedative with anti-inflammatory properties, in reducing the incidence of postoperative atrial fibrillation (POAF) in patients undergoing coronary artery bypass grafting (CABG). The study will enroll 50 patients, who will be randomly assigned to receive either remimazolam or a control treatment. Blood levels of inflammatory markers, stress hormones, and myocardial injury indicators will be measured to assess the drug's impact. This pilot study aims to gather data for a larger double-blind randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50-70 years undergoing selective CABG surgery with a BMI between 18-28 kg/m2.
Not a fit: Patients undergoing emergency surgery or those with pre-existing cardiac conditions or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to significantly reduce the occurrence of postoperative atrial fibrillation in heart surgery patients.
How similar studies have performed: While the use of remimazolam is novel in this context, other studies have shown promising results with anti-inflammatory approaches to reduce postoperative complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 50-70 years old; * BMI 18-28 kg/m2； * Selective CABG surgery will be performed at the Yangzhou Institute Heart and Great Vessels, the Affiliated Hospital of Yangzhou University, Yangzhou, China. * Patients agree to participate in this study and sign the informed consent form. Exclusion Criteria: * Emergency surgery; * with any other type of cardiac surgery; * pre-operative supraventricular arrhythmia; * with moderate or severe valve disease before surgery; * with a history of chemotherapy or radiotherapy; * with a history of thoracic or cardiovascular surgery; * diuretics usage before the surgery.
Where this trial is running
Yangzhou, Jiangsu
- The Affiliated Hospital of Yangzhou University. — Yangzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaojun He, MD, Ph.D.
- Email: xhe34baltimore@163.com
- Phone: +86-13524954567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.