An interventional study of Remimazolam besylate and Propofol/ Sevoflurane in Aortic Valve Stenosis and Remimazolam, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Other
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 64 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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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
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
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
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
Total dose of vasopressors and inotropics used.
Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.
Time frame: Start of anesthesia to end of anesthesia
Hypotension and bradycardia event duration
Hypotension and bradycardia event duration will be compared
Time frame: Start of anesthesia to end of anesthesia
Extubation time
Extubation time between the two groups will be compared
Time frame: End of anesthesia to extubation
Emergence agitation
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.
Time frame: Arrival of patient at ICU
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital