Remimazolam and Propofol Anesthesia in Elderly Patients

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201300
• Other study ID #: AJIRB-MED-INT-21-651
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: July 2023
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 18, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Drug:
• Remimazolam Besylate 6 mg/kg/hr
Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.
• Remimazolam Besylate 12 mg/kg/hr
Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.
• Propofol
Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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