Aortic Valve Stenosis, Remimazolam
Conditions
Keywords
Aortic Valve Stenosis, Remimazolam
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.
Interventions
DRUGRemimazolam 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.
DRUGPropofol/ 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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of vasopressors and inotropics used. | Start of anesthesia to end of anesthesia | Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension and bradycardia event duration | Start of anesthesia to end of anesthesia | Hypotension and bradycardia event duration will be compared |
| Extubation time | End of anesthesia to extubation | Extubation time between the two groups will be compared |
| Emergence agitation | 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. |
Countries
South Korea
Outcome results
None listed