A Novel Standardized Dexmedetomidine Nasal Spray Formulation for Procedural Sedation During Venous Port Implantation: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background: Noninvasive sedative approaches are increasingly valued in ambulatory anesthesia. The aim of this study was to evaluate the efficacy and safety of the novel standardized dexmedetomidine nasal spray for procedural sedation in adult patients undergoing port implantation under local anesthesia. Methods: Eighty-two patients undergoing port implantation under local anesthesia were enrolled in this study. The patients were randomly allocated to receive nasal spray with 100μg dexmedetomidine or placebo with saline, 30 min prior to the procedure. The primary outcome was the postoperative anesthesia satisfaction assessed using Iowa Satisfaction with Anesthesia Scale (ISAS; 11-item mean score, -3 to +3). The secondary outcomes included the Ramsay sedation scale (RSS), visual analog scale (VAS), postoperative sleep quality, hemodynamic changes, and the incidence of adverse events. Results: Compared with placebo, dexmedetomidine significantly improved satisfaction with procedure (ISAS median [IQR] was 2.7 [2.5-2.8] vs 2.1 [1.8-2.4]; P