Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients

Seoul National University

Status: Completed

Conditions: Hemodynamic Instability

Treatments: Drug: Rocuronium; Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Sufentanil; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05423951

Remimazolam_OPCAB

Details and patient eligibility

About

Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.

Enrollment: 106 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting

Exclusion criteria

• Patients who refuse to participate
• Concomitant heart valve surgery or thoracic aorta surgery
• Emergent surgery
• Preoperative sedation
• Intubated state
• Patients with mechanical circulatory assist device
• Preoperative use of inotropes or vasopressors
• History of allergy or adverse reaction to study drugs
• Rapid sequence intubation
• Lactose intolerance
• Peanut allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

106 participants in 2 patient groups

Remimazolam

Experimental group

Treatment:

Drug: Sufentanil

Drug: Rocuronium

Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]

Propofol

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Rocuronium

Drug: Propofol