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Clinical trial

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

ID
Name
AJIRB-MED-INT-21-651
Description
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.
Trial arms
Trial start
2022-02-02
Estimated PCD
2022-11-25
Trial end
2023-01-18
Status
Completed
Treatment
Remimazolam Besylate 6 mg/kg/hr
Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.
Arms:
Remimazolam 6
Other names:
Byfavo
Remimazolam Besylate 12 mg/kg/hr
Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.
Arms:
Remimazolam 12
Other names:
Byfavo
Propofol
Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.
Arms:
Propofol
Other names:
Fresofol
Size
69
Primary endpoint
difference in the decreased mean arterial pressure
from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 69, 'type': 'ACTUAL'}}
Updated at
2023-07-25

1 organization

2 products

1 indication

Organization
Ajou University School of Medicine
Product
Remimazolam Besylate
Indication
Hemodynamics
Product
Propofol