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Clinical trial

Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Patients Undergoing Minimally Invasive Aortic Valve Replacement Surgery : A Prospective Randomized Controlled Study

ID
Name
05-2023-105
Description
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.
Trial arms
Trial start
2023-06-29
Estimated PCD
2024-06-30
Trial end
2024-06-30
Status
Recruiting
Treatment
Remimazolam besylate
During induction, patients allocated to the remimazolam group will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combied with remifetanil.
Arms:
Remimazolam
Other names:
Remimazolam besylate, Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea
Propofol/ Sevoflurane
During induction, patients allocated to the P/S group will receive propofol 1% 1-2mg/kg with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with sevoflurane and remifentanil.
Arms:
Propofol/sevoflurane
Other names:
Fresofol 1% TM, Fresenius
Size
52
Primary endpoint
Total dose of vasopressors and inotropics used.
Start of anesthesia to end of anesthesia
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2023-09-26

1 organization

2 products

2 indications

Organization
Pusan National University Yangsan Hospital
Product
Remimazolam
Indication
Aortic Valve Stenosis
Indication
Remimazolam
Product
Propofol + Sevoflurane