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

Area of Science:

• Gastroenterology
• Anesthesiology
• Clinical Pharmacology

Background:

• Sedation protocols for balloon-assisted enteroscopy (BAE) lack standardization.
• Midazolam is commonly used for BAE sedation, but administration methods vary.
• Comparing continuous infusion versus intermittent bolus midazolam is crucial for optimizing BAE procedures.

Purpose of the Study:

• To compare the efficacy and safety of continuous midazolam infusion versus intermittent bolus administration during BAE.
• To determine if continuous infusion provides a greater proportion of time under conscious sedation (Ramsay Sedation Scale score of 3-4).
• To evaluate secondary outcomes including procedure interruptions, patient and endoscopist satisfaction, drug dosage, and adverse events.

Main Methods:

• A multicenter, prospective, double-blind, randomized controlled trial was conducted across 15 Japanese National Hospital Organization institutions.
• Patients undergoing diagnostic or therapeutic BAE were randomized to receive either continuous intravenous midazolam infusion or intermittent bolus administration.
• The primary endpoint was the proportion of time spent in conscious sedation, with secondary endpoints assessing procedural and safety parameters.

Main Results:

• The proportion of time under conscious sedation was similar between the continuous infusion and intermittent bolus groups (0.637±0.315 vs. 0.609±0.272, p=0.721).
• The continuous infusion group exhibited a trend towards fewer body movements causing procedure interruption (7.9% vs. 25.0%, p=0.091).
• Continuous infusion required a higher total midazolam dose, but adverse event incidence was comparable between groups.

Conclusions:

• Continuous midazolam infusion did not prove superior to intermittent bolus administration in maintaining conscious sedation during BAE.
• Continuous infusion effectively suppressed body movements during BAE without an increase in adverse events.
• Continuous midazolam infusion represents a viable sedation strategy for BAE procedures in clinical practice.