Midazolam in upper gastrointestinal endoscopy: a single-blind dose-finding study.

Area of Science:

• Pharmacology
• Gastroenterology

Background:

• Midazolam is a water-soluble benzodiazepine known for its sedative and amnestic effects.
• Upper endoscopy requires adequate sedation for patient comfort and procedural success.

Purpose of the Study:

• To evaluate the efficacy of increasing midazolam dosages (0.05, 0.10, 0.15, 0.20 mg/kg) for sedation during upper endoscopy in unpremedicated patients.
• To determine the optimal midazolam dosage for satisfactory sedation and minimal adverse effects.

Main Methods:

• An open, non-randomized study involving 60 unpremedicated patients undergoing diagnostic upper endoscopy.
• Efficacy was assessed using the Trieger test (psychomotor function), anterograde amnesia, patient rating (PR) of sedation, and physician's global assessment (PGA).

Main Results:

• Patient rating (PR) for sedation was consistently excellent-good across all tested midazolam doses.
• Anterograde amnesia was observed in nearly all patients.
• Psychomotor function (Trieger test) showed dose-dependent deterioration (p < 0.05).
• Physician's global assessment (PGA) significantly improved with increasing dosage, from 26.7% at 0.05 mg/kg to 80.0% at 0.20 mg/kg (p < 0.01).
• Treatment failure, requiring supplemental diazepam, occurred in 8/15 patients at 0.05 mg/kg, and 1 patient each at 0.10 and 0.15 mg/kg.
• No significant changes in vital signs were noted. Phlebitis occurred in two patients receiving both midazolam and diazepam.

Conclusions:

• Midazolam is well-tolerated and provides satisfactory sedation for upper endoscopy.
• In the absence of premedication, dosages exceeding 0.10 mg/kg do not offer additional benefits for sedation efficacy.
• The optimal dose for unpremedicated patients undergoing upper endoscopy appears to be 0.10 mg/kg.