Remimazolam for Postoperative Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorYangzhou University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Emergency surgery;

with any other type of cardiac surgery;

pre-operative supraventricular arrhythmia;

with moderate or severe valve disease before surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    Remimazolam is dispensed at 2 mg/ml by the designated researchers who are not involved in enrollment, anesthesia administration, and postoperative follow-up.

  • midazolam

    Drug

    Midazolam is dispensed at 1 mg/ml by the designated researchers who are not involved in enrollment, anesthesia administration, and postoperative follow-up.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Remimazolam groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

postoperative Atrial Fibrillation (POAF)

POAF is defined as postoperative new-onset Atrial Fibrillation (AF) lasting more than the 30 s or hemodynamic instability requiring treatment. AF is defined as 1) irregular R-R interval (in the presence of AV conduction), 2) P-wave disappearance, and 3) irregular atrial activity according to the AHA guidelines.

Time frame
7 days after the operation.

Secondary outcomes

1

Inflammatory factors

Blood level of TNF-α

Time frame
1) immediately after the operation, 2) 24 hours after the operation.
2

Stress factors

Blood level of epinephrine, norepinephrine, cortisol, adrenocorticotropic hormone, corticotropin-releasing hormone.

Time frame
1) immediately after the operation, 2) 24 hours after the operation.

Other outcomes

1

Myocardial injury markers

Myocardial injury markers (cTnT, cTnI, CK-MB)

Time frame
7 days after the operation.
2

Arterial blood pressure (BP)

Hemodynamic parameters

Time frame
7 days after the operation.
3

Cardiac index (CI)

Hemodynamic parameters

Time frame
7 days after the operation.
4

systemic vascular resistance (SVR)

Hemodynamic parameters

Time frame
7 days after the operation.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.