Remimazolam and Propofol Anesthesia in Elderly Patients

Not Applicable

Completed

• Conditions: Hemodynamics
• Interventions: Drug: Remimazolam Besylate 6 mg/kg/hr; Drug: Remimazolam Besylate 12 mg/kg/hr; Drug: Propofol

• Registration Number: NCT05201300
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-15
• Study First Posted: 2022-01-21
• Study Start: 2022-02-02
• Primary Completion: 2022-11-25
• Study Completion: 2023-01-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam 6	Remimazolam Besylate 6 mg/kg/hr	Remimazolam starts at 6 mg/kg/hr until loss of consciousness
Remimazolam 12	Remimazolam Besylate 12 mg/kg/hr	Remimazolam starts at 12 mg/kg/hr until loss of consciousness
Propofol	Propofol	Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of