A Pilot Study on the Efficacy and Safety of Sedation With Remimazolam in Japanese Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

OBJECTIVES: Remimazolam is a novel, ultra-short-acting benzodiazepine. Remimazolam is characterized by rapid induction and recovery and low cardiopulmonary effects. The present study aimed to examine the safety and efficacy of a sedation method combining remimazolam and pentazocine during endoscopic retrograde cholangiopancreatography (ERCP) in a Japanese cohort. METHODS: The present investigation was a single-center, single-arm, Phase 2 study. The primary endpoint was successful endoscopic sedation. The initial dose was induced with remimazolam (0.1 mg/kg) and pentazocine (3.75 mg). Remimazolam (0.05 mg/kg) and the same dose of pentazocine as the initial dose were added as needed in response to body movements or signs of discomfort during the procedure. RESULTS: A total of 59 patients [median age (range): 75 years (48-87 years), 47 male (79.7%)] were enrolled. Successful endoscopic sedation was achieved in all patients. One patient (1.7%) experienced transient circulatory depression, with no instances of respiratory depression or need for flumazenil reversal. Post-procedure alertness was achieved within 5 and 10 min in 52 (88.1%) and 58 patients (98.3%), respectively. CONCLUSION: Sedation with remimazolam and pentazocine in ERCP demonstrated high efficacy and a favorable safety profile in the Japanese population. TRIAL REGISTRATION: This trial was registered in the Japan Registry of Clinical Trials (jRCTs051230088).