Remimazolam and Propofol Anesthesia in Elderly Patients

Ajou University School of Medicine

Status: Completed

Conditions: Hemodynamics

Treatments: Drug: Remimazolam Besylate 6 mg/kg/hr; Drug: Remimazolam Besylate 12 mg/kg/hr; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05201300

AJIRB-MED-INT-21-651

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

69 participants in 3 patient groups

Remimazolam 6

Experimental group

Description:

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

Treatment:

Drug: Remimazolam Besylate 6 mg/kg/hr

Remimazolam 12

Experimental group

Description:

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

Treatment:

Drug: Remimazolam Besylate 12 mg/kg/hr

Propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol