Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients underwent endoscopy: a double-blind, randomized controlled clinical trial.

Abstract

Background: Digestive endoscopy (DE) is uncomfortable for most patients. Lorazepam is a potent benzodiazepine with anxiolytic and sedative effects.

Objective: This study aims to determine the sedative effect of sublingual lorazepam versus placebo as a premedication in patients who underwent DE.

Design: This is a mono-center, double-blind, and randomized controlled trial.

Methods: A lorazepam sublingual tablet was made by researchers and physical tests were done on it, then the double-blind placebo-controlled trial was done to investigate the efficacy of 2 mg sublingually administered lorazepam as a premedication for endoscopy. Lorazepam or a placebo tablet was administered sublingually 30 min before the endoscopy. The patients, nurses, and physicians were blinded to the patient group. The depth of sedation was evaluated according to the American Society of Anesthesiology.

Results: In all, 116 patients were randomly assigned to take either lorazepam (n = 58) or a placebo (n = 58). The results of physical properties tests were acceptable according to United States Pharmacopeia. There were no statistical differences between groups regarding age and gender. In the lorazepam group, 75.8% of patients showed mild sedation, and 24.2% of patients showed no sedation. All of the patients in the placebo had no sedation (p = 0.001). Time of procedure (p < 0.001), intraoperative O₂ saturation (p < 0.001), intraoperative heart rate (p < 0.001), and intraoperative blood pressure (p < 0.001) were significantly lower in the lorazepam group. No significant or dangerous side effects were observed except a bit of giddiness and dizziness.

Conclusion: The results of this study showed that prescription of sublingual lorazepam 25-30 min before endoscopy provided mild sedation.

Registration: IRCT201611039014N130 (05/11/2016); https://en.irct.ir/trial/9568.