NCT05891145 Remimazolam for Postoperative Atrial Fibrillation
| NCT ID | NCT05891145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yangzhou University |
| Condition | Coronary Artery Bypass Grafting |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-02-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Atrial fibrillation (AF) is the most common cardiac severe arrhythmia globally and is associated with an increased risk of mortality and morbidity, with a loss of 6.0 million disability-adjusted life-years worldwide in 2017, conferring 0.24% of total disability-adjusted life-years globally. Due to the absence of knowledge of AF pathogenesis, currently, available therapies do not prevent AF onset or progression in 85% of patients. Despite the identification of novel druggable targets that are involved in the pathogenesis of AF, the translation of these findings to clinical drug studies is limited. Postoperative atrial fibrillation (POAF) is the most common type of secondary AF. The incidence of POAF after coronary artery bypass grafting (CABG) is approximately 30%. About 16% of patients developed POAF in cardiac surgery even with the international guideline recommended perioperative beta-blocker intervention. Remimazolam is a newly approved benzodiazepine sedative indicated for the induction and maintenance of procedural sedation in adults, with significantly reduced sedation and recovery time. It was also found to be with an anti-inflammatory effect and therefore might have an impact on POAF since AF is closely related to the inflammatory response of myocardial tissue and inflammatory factors such as TNF-α. So, the RePAF trial intends to explore whether remimazolam application in induction and maintenance for general anesthesia during cardiac surgery can reduce the incidence of POAF in patients with CABG, and the effect on the postoperative plasma levels of inflammatory factors and stress factors.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05891145 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 70 Years, studying Coronary Artery Bypass Grafting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05891145 currently recruiting?
Yes, NCT05891145 is actively recruiting participants. Contact the research team at xhe34baltimore@163.com for enrollment information.
Where is the NCT05891145 trial being conducted?
This trial is being conducted at Yangzhou, China.
Who is sponsoring the NCT05891145 clinical trial?
NCT05891145 is sponsored by Yangzhou University. The trial plans to enroll 50 participants.