Dexmedetomidine nasal spray for patients undergoing endoscopic retrograde cholangiopancreatography: protocol for a randomized controlled trial

Endoscopic retrograde cholangiopancreatography (ERCP) is associated with significant discomfort and necessitates adequate sedation. This study aims to determine the effect of dexmedetomidine nasal spray adjunct to propofol sedation for patients undergoing ERCP procedures. This randomized, double-blind, placebo-controlled trial will be conducted at a tertiary teaching hospital in eastern China. Approximately 15 min before sedation, 160 adult patients will be randomly assigned (1:1) to either the dexmedetomidine group (dexmedetomidine nasal spray; n = 80) or the control group (normal saline nasal spray; n = 80). Sedation will be achieved with a target-controlled infusion of propofol, titrated to Modified Observer’s Assessment of Alertness/Sedation scores of 1 and 2. The primary endpoint is the total propofol consumption during sedation. Secondary endpoints include the composite incidence of hypotension and hypoxemia during the procedures and recovery; and fatigue scores 15 min after emergence from sedation. An independent Data and Safety Monitoring Committee will conduct an ongoing review of study implementation. We anticipate that preoperative dexmedetomidine nasal spray will decrease total propofol requirements, reduce sedation-related adverse events, and enhance recovery for patients undergoing ERCP. Chinese Clinical Trial Registry (ChiCTR2400093656) on December 10, 2024.