Comparing anesthesia effects on heart stability during aortic valve surgery
Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Patients Undergoing Minimally Invasive Aortic Valve Replacement Surgery : A Prospective Randomized Controlled Study
This study is testing whether a newer anesthetic called remimazolam works better than the traditional sevoflurane to keep patients with severe aortic valve stenosis stable during minimally invasive heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan, Gyeongsangnam-do) |
| Trial ID | NCT05864625 on ClinicalTrials.gov |
What this trial studies
This study compares the hemodynamic stability of two anesthetic agents, remimazolam and sevoflurane, in patients with severe aortic valve stenosis undergoing minimally invasive aortic valve replacement surgery. It aims to assess how these agents affect intraoperative hemodynamics, particularly in preventing hypotension, which can be dangerous for these patients. Remimazolam is a newer anesthetic known for its rapid action and stability, and this study seeks to provide definitive data on its effectiveness compared to traditional sevoflurane anesthesia.
Who should consider this trial
Good fit: Ideal candidates are patients over 19 years old with severe aortic stenosis scheduled for minimally invasive aortic valve replacement surgery.
Not a fit: Patients with known allergies to benzodiazepines or propofol, those with certain comorbidities, or those requiring emergency operations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices for patients with severe aortic stenosis, reducing the risk of hypotension during surgery.
How similar studies have performed: Previous studies have shown that remimazolam can be safely used in cardiac anesthesia, but this specific comparison with sevoflurane is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yangsan, Gyeongsangnam-do
- Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hee Young Kim, MD, PhD
- Email: yuvi1981@naver.com
- Phone: 820553602129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.