Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam Besylate 6 mg/kg/hr
- Conditions
- Hemodynamics
- Sponsor
- Ajou University School of Medicine
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- difference in the decreased mean arterial pressure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Jong Yeop Kim
Professor
Ajou University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •ASA I, II patients over 65 years old undergoing general anesthesia
Exclusion Criteria
- •cardiac surgery
- •neurosurgery
- •liver surgery
- •uncontrolled hypertension
- •bronchial asthma
- •body mass index ≥ 30 kg/m2
- •severe heart, liver, kidney disease
Arms & Interventions
Remimazolam 6
Remimazolam starts at 6 mg/kg/hr until loss of consciousness
Intervention: Remimazolam Besylate 6 mg/kg/hr
Remimazolam 12
Remimazolam starts at 12 mg/kg/hr until loss of consciousness
Intervention: Remimazolam Besylate 12 mg/kg/hr
Propofol
Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness.
Intervention: Propofol
Outcomes
Primary Outcomes
difference in the decreased mean arterial pressure
Time Frame: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
difference between baseline mean arterial pressure and lowest mean arterial pressure