Remimazolam and Propofol Anesthesia in Elderly Patients

NCT05201300 | Completed

• 1 other identifier: AJIRB-MED-INT-21-651
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (1)

• difference in the decreased mean arterial pressure

  difference between baseline mean arterial pressure and lowest mean arterial pressure

  from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation

Study Arms (3)

Remimazolam 6

EXPERIMENTAL

Remimazolam starts at 6 mg/kg/hr until loss of consciousness

Drug: Remimazolam Besylate 6 mg/kg/hr

Remimazolam 12

EXPERIMENTAL

Remimazolam starts at 12 mg/kg/hr until loss of consciousness

Drug: Remimazolam Besylate 12 mg/kg/hr

Propofol

ACTIVE COMPARATOR

Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness.

Drug: Propofol

Interventions

Remimazolam Besylate 6 mg/kg/hr DRUG

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

Also known as: Byfavo

Remimazolam 6

Remimazolam Besylate 12 mg/kg/hr DRUG

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

Also known as: Byfavo

Remimazolam 12

Propofol DRUG

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

Also known as: Fresofol

Propofol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ASA I, II patients over 65 years old undergoing general anesthesia

You may not qualify if:

• cardiac surgery
• neurosurgery
• liver surgery
• uncontrolled hypertension
• bronchial asthma
• body mass index ≥ 30 kg/m2
• severe heart, liver, kidney disease

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 21, 2022
• Study Start: February 2, 2022
• Primary Completion: November 25, 2022
• Study Completion: January 18, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

KR (1)