Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
NCT Number: NCT05864625
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.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Not applicable
Yangsan, Gyeongsangnam-do, 50612, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Start of anesthesia to end of anesthesia
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 will be compared
Time frame: End of anesthesia to extubation
Extubation time between the two groups will be compared
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.
Pusan National University Yangsan Hospital
Other
Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Patients Undergoing Minimally Invasive Aortic Valve Replacement Surgery : A Prospective Randomized Controlled Study
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.
Published trials that share one or more normalized conditions with this study.
NCT02729519
Aortic Valve Disease, Aortic Valve Stenosis
Montpellier, France
View Trial DetailsNCT07605780
Aortic Valve Disease, Aortic Valve Stenosis
Brescia, BS, Italy
View Trial DetailsNCT06171802
Aortic Valve Disease, Aortic Valve Stenosis
Copenhagen, Denmark
View Trial DetailsNCT05774691
Aortic Valve Disease, Aortic Valve Stenosis
Aalst, Belgium
View Trial Details