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

NCT ID: NCT05864625

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-29
• Study Completion Date: 2025-06-10

Brief 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.

Detailed 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.

Conditions

Aortic Valve Stenosis; Remimazolam

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Remimazolam

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.

Group Type: EXPERIMENTAL

Remimazolam besylate

Intervention Type: DRUG

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.

Propofol/sevoflurane

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.

Group Type: ACTIVE_COMPARATOR

Propofol/ Sevoflurane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Remimazolam besylate, Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea; Fresofol 1% TM, Fresenius

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kim Hee Young

Assistant professor for fund

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Young Kim, MD, PhD

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Countries

South Korea

Other Identifiers

05-2023-105

Identifier Type: -

Identifier Source: org_study_id