Remimazolam for Postoperative Atrial Fibrillation
Recruiting · NCT05891145 · Interventional (participants receive a specific treatment) · Lead sponsor: Yangzhou University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- The Affiliated Hospital of Yangzhou University. - Yangzhou, Jiangsu, China