Comparison of sedation efficacy and safety between dexmedetomidine and propofol during endoscopic retrograde cholangiopancreatography: A prospective, randomized, single-blinded trial

Abstract

Abstract What is known and objective: Propofol-balanced sedation is widely used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, but sedation-related adverse events (SRAEs) commonly occur. The combination of dexmedetomidine with opioids and benzodiazepines has provided effective sedation with a superlative degree of safety during different clinical scenarios. The aim of this study was to compare the sedation efficacy and safety between dexmedetomidine and propofol with a balanced administration of opioids and benzodiazepines during ERCP procedures. Methods: Forty-one patients were randomly divided into two groups, the dexmedetomidine (DEX) group and the propofol (PRO) group. As a premedication, all participants received an intravenous bolus dose of 0.02 mg·kg-1 midazolam and 0.2 μg·kg-1 sufentanil. Patients in the DEX group received an additional bolus of 0.6 μg·kg-1 dexmedetomidine over 2 min followed by a dexmedetomidine infusion at 1.2 μg·kg-1·h-1, whereas the PRO group received 1–2 mg·kg-1 propofol bolus over 30 s followed by a propofol infusion at 2–3 mg·kg-1·h-1. The primary outcome was the incidence of hypoxemia (SpO2 < 90% for > 10 s) during ERCP. Results: All patients achieved the targeted sedation level on the Ramsay Sedation Scale ³ 4. When compared with the PRO group, the incidence of hypoxemia was significantly reduced in the DEX group. Respiratory depression (respiratory rate of < 10 bpm·min-1) was more frequently observed among PRO patients than DEX patients. During the procedures, endoscopists’ and patients’ satisfaction scores were comparable between groups, as were patients’ pain and amnesia scores. What is new and conclusion: Dexmedetomidine provided satisfactory sedation safety with no downstream effects on sedation efficacy when performing ERCP in comparison with propofol in combination with opioids and benzodiazepines.