Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Minimally Invasive AVR

Phase

N/A

Condition

N/A

Treatment

Propofol/ Sevoflurane

Remimazolam besylate

Clinical Study ID

NCT05864625

05-2023-105

Ages > 19
All Genders

Study Summary

Anesthetic agents can cause hypotension, and be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse. Remimazolam is known for its hemodynamic stability compared to propofol. This study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients with severe aortic valve stenosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients over 19 years old
Patients with severe aortic stenosis, undergoing minimally invasive aortic valvereplacement surgery

Exclusion

Exclusion Criteria:

Patients with known allergy to benzodiazepine, flumazenil, propofol
Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactosemalabsorption
Patients with hypersensitivity to Dextran40
Patients who have been taking benzodiazepine for long term
Patients with whom heart rate assessment is not accurate, such as atrialfibrillation
Patients with end stage renal disease requiring hemodialysis
Patients with history of acute angle glaucoma
Patients with valve disease severity of grade III or higher, other than aortic valve
Emergency operation

Study Design

Propofol/ Sevoflurane

June 29, 2023

June 10, 2025

Study Description

Anesthetic agents can cause hypotension due to reduced cardiac contractility and vasodilation. This can be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse in extreme cases. Remimazolam is a relatively new anesthetic agent and it is a ultra-short acting benzodiazepine with a context sensitive half time of 7.5 minutes. Remimazolam is known for its hemodynamic stability compared to propofol. Previous studies have also shown that remimazolam can be safely used in patients with severe aortic stenosis and in cardiac anesthesia induction and during cardiopulmonary bypass. However, there is no definite data on comparison of hemodynamic variables between remimazolam based total intravenous anesthesia (TIVA) and conventional propofol induction and sevoflurane maintenance anesthesia. Therefore, this study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients undergoing minimally invasive aortic valve replacement surgery.

Connect with a study center

Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do 50612
Korea, Republic of
Site Not Available

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