Actively Recruiting

Phase Not Applicable
Age: 50Years - 70Years
All Genders
NCT05891145

Remimazolam for Postoperative Atrial Fibrillation

Led by Yangzhou University · Updated on 2023-06-06

50

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Remimazolam for Postoperative Atrial Fibrillation

Who Can Participate

Age: 50Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 to 70 years
  • Body mass index (BMI) between 18 and 28 kg/m2
  • Scheduled for selective coronary artery bypass grafting (CABG) surgery at Yangzhou Institute Heart and Great Vessels, Affiliated Hospital of Yangzhou University, China
  • Agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Undergoing any other type of cardiac surgery
  • Pre-operative supraventricular arrhythmia
  • Moderate or severe valve disease before surgery
  • History of chemotherapy or radiotherapy
  • History of thoracic or cardiovascular surgery
  • Use of diuretics before surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Affiliated Hospital of Yangzhou University.

Yangzhou, Jiangsu, China, 225000

Actively Recruiting

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Research Team

X

Xiaojun He, MD, Ph.D.

CONTACT

Z

Zhuan Zhang, MD, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Remimazolam for Postoperative Atrial Fibrillation | DecenTrialz