NCT05891145Recruiting
Remimazolam for Postoperative Atrial Fibrillation
The Effect of Remimazolam on Postoperative New-onset Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting
Source: ClinicalTrials.gov · Last updated 6 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 May 2023
- Start date
- 1 Feb 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Yangzhou University
- NCT number
- NCT05891145
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Feb 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery;
- diuretics usage before the surgery.
Other illness
- 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;
Who the study is looking for
- 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.
Age in the registry: 50 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Yangzhou University. Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.