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NCT05864625 | RECRUITING | Aortic Valve Stenosis

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

Pusan ​​National University Yang Hospital

Information provided by (Responsible Party):

Kim Hee Young

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.

Condition or disease

Aortic Valve Stenosis

For remimazol

Intervention/treatment

Remimazolam besylate

Propofol/ Sevoflurane

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : SINGLE
Primary Purpose : OTHER
Official 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
Actual Study Start Date : 2023-06-29
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Minimally Invasive AVR

Location Details

NCT05864625

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Locations

RECRUITING

Korea, Republic of, Gyeongsangnam-do

Pusan ​​National University Yang Hospital

The, Gyeongsangnam-do, Korea, Republic of, 50612