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

Yuko Sakakibara1, Tomohiko Mannami2, Toshio Kuwai3

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Continuous midazolam infusion for balloon-assisted enteroscopy (BAE) did not improve sedation time compared to intermittent bolus. However, continuous infusion reduced patient movement during BAE without increasing adverse events, offering a feasible sedation option.

Keywords:
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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.