Preoperative Lansoprazole With or Without Domperidone and Gastric Content Characteristics: A Randomized Placebo-Controlled Trial
Abstract
Background: Preoperative pharmacological strategies may modify gastric pH and volume, two characteristics relevant to the potential consequences of pulmonary aspiration. This randomized, placebo-controlled trial evaluated the effects of two consecutive doses of lansoprazole, alone or combined with domperidone, on preoperative gastric contents in patients undergoing elective surgery. The primary outcomes were gastric pH and gastric volume. Secondary outcomes included Hay’s Sulphur test positivity and the proportions of patients meeting the predefined gastric pH and volume criteria.
Materials and Methods: A total of 180 consecutive patients with American Society of Anesthesiologists physical status I–II undergoing elective surgery under general anesthesia were enrolled in this randomized, placebo-controlled, blinded trial and allocated equally to placebo (Group C), lansoprazole 30 mg (Group L), or lansoprazole 30 mg plus domperidone 10 mg (Group LD). Two oral doses were administered on the evening before and morning of surgery. Gastric contents were aspirated after tracheal intubation. Gastric pH and volume were the primary outcomes. Hay’s Sulphur test positivity and the proportions of patients meeting the predefined criteria of pH ≤2.5, volume ≥25 mL, or both were secondary outcomes.
Results: Gastric contents were obtained from 177 patients. After exclusion of Hay’s Sulphur-positive samples from pH and volume analyses, 38, 43, and 54 patients were evaluable in Groups C, L,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 180 participants or records.
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