Efficacy and Safety of Ciprofol for General Anesthesia in Transcatheter Aortic Valve Replacement: A Study Protocol for a Randomized Controlled Trial

Abstract

Abstract Background: Patients who have gone through transcatheter aortic valve replacement (TAVR) and have experienced a decrease in physical and physiological capabilities are more likely to experience unfavorable cardiovascular reactions, including hypotension during induction of anesthesia. Due to the impaired cardiac function of these patients, maintaining hemodynamic stability during anesthesia induction can be challenging. Ciprofol, a novel anesthetic and a version of propofol, brings about a speedy onset, a brief recovery time, reduced injection pain, and consistent cardiorespiratory functioning. This study aims to investigate the effectiveness and safety of ciprofol in induction and maintaining general anesthesia in patients undergoing TAVR to establish its potential use in clinical practice. Methods: 124 elderly patients aged 65–80 undergoing elective TAVR with general anesthesia will be randomly assigned to two parallel groups in this single-center trial. Patients will be randomly allocated to receive either ciprofol or propofol for induction. The primary outcome is the area under the baseline of the mean arterial pressure (MAP) over the first 15 minutes after induction. Hypotension will be identified as a decrease in MAP below 65 mmHg or more than 20% from the initial value during induction. Secondary outcomes include the incidence of adverse events, such as hypotension, bradycardia, nausea and vomiting, stroke, covert central nervous system injury, myocardial infarction, and acute kidney injury, as well as the cumulative doses of vasoactive drugs, the occurrence and intensity of injection pain, and ScO2 values less than 55% of the area under the curve (AUC). Discussion: This study will provide valuable information on the effectiveness and safety of ciprofol as a general anesthetic for patients undergoing TAVR. Trial registration: ClinicalTrials.gov (NCT05881291).