Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06496165
NA

Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.

Official title: Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients:a Prospective, Single Blinded, Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2024-07-15

Completion Date

2026-12-31

Last Updated

2024-07-11

Healthy Volunteers

No

Interventions

DRUG

Remimazolam

Intravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0

DRUG

Propofol

Intravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0

Locations (1)

Zhongshan Hospital Fudan university

Shanghai, Shanghai Municipality, China