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

Jie Tong,1,* Mengping Wei,1,* Zhixiang Ye,1,* Huayuan Gao,1 Weifeng Hong,1 Peiling Cai,1 Wenjun Li,1 Jie Wang,2 Xiushi Zhou,3 Chao Liang,1,2,* Zhiyao Wang2,* 1Department of Anesthesiology, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, People’s Republic of China; 2Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China; 3Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, 27701, USA*These authors contributed equally to this workCorrespondence: Zhiyao Wang, Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China, Email [email protected] Chao Liang, Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China, Email [email protected]: 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< 0.001), indicating a clinically relevant improvement in patient experience during outpatient port implantation under local anesthesia, and postoperative sleep quality (4.4± 0.8 vs 3.1± 0.8, P< 0.001) during the first postoperative night. The incidence of adverse events and other secondary outcomes were comparable between the two groups.Conclusion: A standardized dexmedetomidine nasal spray provided reliable, well-tolerated sedation, enhanced postoperative comfort, and improved postoperative sleep quality in adults undergoing minor procedures under local anesthesia. These findings support its feasibility as a noninvasive option for outpatient procedural sedation.Keywords: dexmedetomidine, administration, intranasal, conscious sedation, vascular access devices, patient satisfaction, ambulatory surgical procedures