Mosapride versus Metoclopramide in Critically Ill Patients with Enteral Feeding Intolerance: A Randomized, Double-Blinded Comparison

Eman Mohamed Elmokadem,1,* Dina Khaled Abou El Fadl,1,* Ahmed M Bassiouny,2,3 Amir Eskander Hanna Samy,4 Nouran Omar El Said1,* 1Department of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt; 2Department of Radiodiagnosis, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 3Department of Radiology, Quantum Radiology, Sydney, Australia; 4Critical Care Department, El Matarya Teaching Hospital, Cairo, Egypt*These authors contributed equally to this workCorrespondence: Nouran Omar El Said, Department of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Future University in Egypt, 90th Street, New Cairo, Cairo, 12311, Egypt, Tel +201006526452, Email [email protected]: Enteral feeding intolerance (EFI) from delayed gastric emptying is common in critically ill patients, leading to poor outcomes. Mosapride, a selective 5-HT4 agonist, may be a safer, more effective alternative to metoclopramide, which has limited efficacy due to tachyphylaxis and adverse effects.Objective: To compare the safety and efficacy of mosapride with metoclopramide in reducing gastric residual volume (GRV) and improving enteral nutrition delivery in intensive care unit (ICU) patients with EFI.Methods: In this prospective, randomized, double-blind, double-dummy trial, 100 mechanically ventilated ICU patients with EFI were allocated to receive either mosapride (5 mg enterally every 8 hours plus IV placebo) or metoclopramide (10 mg intravenously every 8 hours plus enteral placebo) for 7 days. GRV was measured daily via ultrasonography. Nutritional adequacy was evaluated through daily caloric and protein intake, calculated from delivered versus prescribed enteral volume. Clinical scores; including Acute Physiology and Chronic Health Evaluation (APACHE II), Sequential Organ Failure Assessment (SOFA), and the Modified Nutrition Risk in Critically Ill (mNUTRIC), as well as ICU length of stay were assessed. Adverse events were continuously monitored using a structured reporting tool.Results: The mosapride group demonstrated a more significant reduction in GRV from day 1 to day 7 (68.03% vs 39.87%, p< 0.001) and higher enteral volume ratio (79.52% vs 69.48%, p< 0.001). Target energy ratio was more frequently achieved in the mosapride group (86% vs 28%, p< 0.001). Improvements in SOFA and mNUTRIC scores were significant only in the mosapride group. Adverse events were comparable between groups (p=0.643). ICU length of stay was non-significantly different between the two groups (p=0.051).Conclusion: Mosapride is more effective than metoclopramide in reducing GRV and enhancing enteral nutrition delivery in critically ill patients with EFI, with a favorable safety profile. These findings support its consideration as a prokinetic agent in this population.Clinical Trial Registration: NCT06826443. Keywords: mosapride, enteral feeding intolerance, gastric residual volume, critically ill patients, prokinetic agents, metoclopramide, gastric emptying