Continuous versus Intermittent Midazolam Sedation in Balloon-Assisted Enteroscopy: A Multicenter Randomized Trial

Introduction: Sedation protocols for balloon-assisted enteroscopy (BAE) are not yet standardized. The aim of this study was to compare the efficacy and safety between continuous infusion and intermittent bolus administration of midazolam for sedation during BAE. The study hypothesis was that continuous infusion would provide a greater proportion of time under conscious sedation than would intermittent bolus administration. Methods: We conducted a multicenter, prospective, double-blind, randomized controlled trial at 15 institutions of the National Hospital Organization in Japan. Patients scheduled for diagnostic or therapeutic BAE were randomly assigned to receive continuous infusion or intermittent bolus administration of intravenous midazolam. The primary endpoint was the proportion of time under conscious sedation, defined as a Ramsay Sedation Scale score of 3–4. Secondary endpoints included body movements causing procedure interruption, endoscopist and patient satisfaction, total drug dosage, adverse events, and termination of the procedure. Results: Of 76 enrolled patients (39 continuous infusion group, 37 intermittent bolus group), one from each group discontinued before treatment, leaving 74 patients (38 continuous group, 36 intermittent bolus group) for analysis. The proportion of time under conscious sedation was comparable between groups (mean ± SD: 0.637 ± 0.315 vs. 0.609 ± 0.272, p = 0.721). However, the continuous infusion group showed a lower incidence of body movements causing procedure interruption (7.9% vs. 25.0%, p = 0.091). The total midazolam dose was higher in the continuous infusion group, whereas the incidence of adverse events was comparable between the two groups. Conclusion: Continuous infusion of midazolam did not demonstrate superiority over intermittent bolus administration with regard to the proportion of time under conscious sedation. However, continuous infusion suppressed body movements during BAE without increasing adverse events; thus, it could be one of the feasible sedation options for BAE in clinical practice.