Abstract
IMPORTANCE: Postinduction hemodynamic instability is a frequent complication among patients with severe aortic stenosis (AS). Using cipepofol as the anesthesia agent may reduce the incidence and severity of hemodynamic instability. OBJECTIVE: To assess whether cipepofol outperforms propofol in maintaining postinduction hemodynamic stability in patients with AS. DESIGN, SETTING, AND PARTICIPANTS: This single-center, randomized clinical trial was conducted from June 29, 2023, to July 8, 2024, at the Second Affiliated Hospital of Zhejiang University School of Medicine in China. Patients with AS scheduled for transcatheter aortic valve replacement (TAVR) were eligible for inclusion. INTERVENTIONS: Participants were randomized 1:1 to receive either cipepofol or propofol as anesthesia induction agents at equipotent doses. MAIN OUTCOMES AND MEASURES: The primary outcome was the area under the curve (AUC) of the mean arterial pressure (MAP) difference from baseline during the initial 15 minutes postinduction. RESULTS: A total of 124 patients with AS scheduled for TAVR were randomized into either the cipepofol group (n = 62) or the propofol group (n = 62). Of 124 patients randomized, 1 patient from each group was excluded due to ineligibility for the TAVR procedure, and data were analyzed for 122 patients (61 patients per group) based on the intention-to-treat principle. Among 122 total patients, mean (SD) age was 72.2 (5.0) years, and 53 patients (43.4%) were female. The cipepofol group exhibited a significantly smaller median (IQR) AUC (-8505.0 mm Hg · s [-12 402.8 to -5130.0]) compared with the propofol group (-13 189.0 mm Hg · s [-17 006.7 to -7593.3]; P < .001). Moreover, compared with the propofol group, the cipepofol group demonstrated a significantly lower incidence of postinduction hypotension (70.5% vs 88.5%; P = .01) and required a smaller median (IQR) dose of norepinephrine during the first 15 minutes postinduction (6.0 μg [0.0-10.0] vs 10.0 μg [5.0-20.0]; P = .006). Additionally, the 2 groups' bispectral indices were comparable. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, cipepofol provided superior hemodynamic stability as an induction agent compared to propofol at equipotent doses and similar anesthesia depths for patients with AS. Therefore, cipepofol could serve as an alternative induction agent to propofol for patients at high cardiovascular risk. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05881291.