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

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Remimazolam; Aortic Valve Stenosis

Treatments: Drug: Remimazolam besylate; Drug: Propofol/ Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT05864625

05-2023-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 19 years old
• Patients with severe aortic stenosis, undergoing minimally invasive aortic valve replacement surgery

Exclusion criteria

• Patients with known allergy to benzodiazepine, flumazenil, propofol
• Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• 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 atrial fibrillation
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Remimazolam

Experimental group

Description:

Induction dose of 6 mg/kg/h of remimazolam with remifentanil TCI 1\~4 nanogram/mL are injected together. When patient loses consciousness, rocuronium 0.8 mg/kg is given and endotracheal intubation is performed after confirming that TOF count is less than one. Anesthesia is maintained by using remimazolam dose of 1mg/kg/h\~2mg/kg/h with remifentanil to maintain optimal depth of anesthesia, which will checked by Sedline value between 25 to 50.

Treatment:

Drug: Remimazolam besylate

Propofol/sevoflurane

Active Comparator group

Description:

1% propofol 1-2mg/kg is injected with remifentanil TCI 1\~4, and when patient loses consciousness, sevoflurane is started and rocuronium 0.8mg/kg is given. After confirming that TOF count is less than one, intubation is performed and anesthesia is maintained with sevoflurane and remifentanil to keep the Sedline value between 25 and 50.

Treatment:

Drug: Propofol/ Sevoflurane