Remimazolam and Propofol Anesthesia in Elderly Patients

NCT ID: NCT05201300

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2023-01-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam 6

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

Group Type: EXPERIMENTAL

Remimazolam Besylate 6 mg/kg/hr

Intervention Type: DRUG

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

Remimazolam 12

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

Group Type: EXPERIMENTAL

Remimazolam Besylate 12 mg/kg/hr

Intervention Type: DRUG

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

Propofol

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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

Interventions

Remimazolam Besylate 6 mg/kg/hr

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

Intervention Type: DRUG

Remimazolam Besylate 12 mg/kg/hr

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

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

Other Intervention Names

Byfavo; Byfavo; Fresofol

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jong Yeop Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-INT-21-651

Identifier Type: -

Identifier Source: org_study_id