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Remimazolam and Propofol Anesthesia in Elderly Patients

NCT05201300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-07-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2022-11-25
Completion
2023-01-18

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201300 on ClinicalTrials.gov