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Completed

NCT Number: NCT05201300

Remimazolam and Propofol Anesthesia in Elderly Patients

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.

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Key information

Conditions

Hemodynamics

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam Besylate 6 mg/kg/hr

Drug

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

Other names: Byfavo

Remimazolam Besylate 12 mg/kg/hr

Drug

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

Other names: Byfavo

Propofol

Drug

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

Other names: Fresofol

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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