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

NCT05864625 | Completed

• 1 other identifier: 05-2023-105
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Remimazolam

Keywords

Aortic Valve Stenosis; Remimazolam

Outcome Measures

Primary Outcomes (1)

• Total dose of vasopressors and inotropics used.

  Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.

  Start of anesthesia to end of anesthesia

Secondary Outcomes (3)

• Hypotension and bradycardia event duration

  Start of anesthesia to end of anesthesia

• Extubation time

  End of anesthesia to extubation

• Emergence agitation

  Arrival of patient at ICU

Study Arms (2)

Remimazolam

EXPERIMENTAL

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.

Drug: Remimazolam besylate

Propofol/sevoflurane

ACTIVE COMPARATOR

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.

Drug: Propofol/ Sevoflurane

Interventions

Remimazolam besylate 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.

Also known as: Remimazolam besylate, Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea

Remimazolam

Propofol/ Sevoflurane 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.

Also known as: Fresofol 1% TM, Fresenius

Propofol/sevoflurane

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Long-Term Synaptic Depression; Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Hee Young Kim, MD, PhD

  Pusan National University Yangsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor for fund

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 29, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)