Remimazolam and Propofol Anesthesia in Elderly Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05201300

Enrollment

Registered

2022-01-21

Start date

2022-02-02

Completion date

2023-01-18

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics

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.

Interventions

DRUGRemimazolam Besylate 6 mg/kg/hr

Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.

DRUGRemimazolam Besylate 12 mg/kg/hr

Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.

DRUGPropofol

Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
difference in the decreased mean arterial pressure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026