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NCT Number: NCT05864625

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Remimazolam besylate, Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea

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.

Other names: Fresofol 1% TM, Fresenius

Primary outcomes

  1. Total dose of vasopressors and inotropics used.

    Time frame: Start of anesthesia to end of anesthesia

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

Secondary outcomes

  1. Hypotension and bradycardia event duration

    Time frame: Start of anesthesia to end of anesthesia

    Hypotension and bradycardia event duration will be compared

  2. Extubation time

    Time frame: End of anesthesia to extubation

    Extubation time between the two groups will be compared

  3. Emergence agitation

    Time frame: Arrival of patient at ICU

    Emergence agitation will be compared between the two groups using Riker Sedation-Agitation Scale upon arrival at ICU. The Riker Sedation-Agitation Scale uses a numeric score from 1 (unarousable) to 7 (dangerous agitation)to assess the level of patient sedation and identifies seven levels of sedation and agitation, which range from deep sedation (unarousable) to dangerous agitation.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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