NCT05423951

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

Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemodynamic Instability

Interventions

Type	Name	Description
DRUG	REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]	For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.
DRUG	Propofol	For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.
DRUG	Rocuronium	After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed
DRUG	Sufentanil	During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-11-08
• Completion: 2023-11-08
• First posted: 2022-06-21
• Last updated: 2023-11-22

Locations

1 site across 1 country: South Korea