Esomeprazole as a prophylactic agent for acid aspiration syndrome in adult patients undergoing elective surgery: A triple blind placebo controlled clinical trial

Abstract

Background: To explore the effect of single oral dose of esomeprazole 20 mg, administered a night before surgery, on intragastric pH and volume in adult patients undergoing elective surgery by excluding cases contaminated with duodenogastric refluxate. Patients and Methods: This prospective, triple blind, randomised and placebo controlled clinical trial was conducted to explore the effect of single oral dose of esomeprazole 20 mg, administered a night before surgery, on intragastric pH and volume on 120 adult inpatients of either sex, American Society of Anaesthesiologist physical status I-II, and aged 15-70 years. The patients in Group C (control) received placebo while Group E (Esomeprazole) received esomeprazole orally at 9.00 pm, the night before elective surgery. On the day of surgery, the gastric contents were aspirated with a large bore, multi-orifice gastric tube passed through an endotracheal tube placed blindly in the oesophagus after tracheal intubation and analysed for pH, volume and the presence of bile salts. Results: Thirty nine samples (33%) out of 117 were contaminated with duodenal contents. Duodenogastric reflux significantly affected pH and volume in Group C (p value 0.0003 and 0.0016) and E (p value 0.0401 and < 0.0001). Esomeprazole, after excluding samples contaminated with duodenal fluid, significantly increased pH (p <0.0001), decreased volume (p 0.0068) and the percentage of the patients (2.56% versus 30.76%) considered "at risk" compared with placebo (p 0.0015) according to the criteria defined (pH ≤ 2.5 and volume ≥ 25 ml). Conclusion: Esomeprazole 20 mg administered orally a night before elective surgery improved the gastric environment (pH < 2.5 and volume > 25 ml/kg) at the time of induction of anaesthesia excluding samples contaminated with duodenogastric reflux.