NCT05201300

Remimazolam and Propofol Anesthesia in Elderly Patients

Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability. A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results. The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.

Conditions

• Hemodynamics

Interventions

Type	Name	Description
DRUG	Remimazolam Besylate 6 mg/kg/hr	Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.
DRUG	Remimazolam Besylate 12 mg/kg/hr	Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.
DRUG	Propofol	Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-11-25
• Completion: 2023-01-18
• First posted: 2022-01-21
• Last updated: 2023-07-25

Locations

1 site across 1 country: South Korea