Remimazolam and Propofol Anesthesia in Elderly Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodynamics

Intervention / Treatment
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* Drug: Remimazolam Besylate 6 mg/kg/hr
* Drug: Remimazolam Besylate 12 mg/kg/hr
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam 6<br>Remimazolam starts at 6 mg/kg/hr until loss of consciousness | Drug: Remimazolam Besylate 6 mg/kg/hr<br>* Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.<br>* Other names: Byfavo;|
| Experimental: Remimazolam 12<br>Remimazolam starts at 12 mg/kg/hr until loss of consciousness | Drug: Remimazolam Besylate 12 mg/kg/hr<br>* Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.<br>* Other names: Byfavo;|
| Active Comparator: Propofol<br>Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness. | Drug: Propofol<br>* Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.<br>* Other names: Fresofol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in the decreased mean arterial pressure | difference between baseline mean arterial pressure and lowest mean arterial pressure | from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation |