drugset / Trial / NCT04433390

Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

NCT04433390 ↗

Phase 3 Completed 305 enrolled CMC Ambroise Paré
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity. Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery. The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.

Timeline

Start
2020-10-14
Primary completion
2022-01-28
Completion
2022-03-03

Outcome

Missed primary endpoint

paper Time-to-transit recovery did not differ between Naloxegol group and placebo (76.0, [IQR 69.3-93.5] vs. 78.3, [IQR 70.0-95.8] h, p value = 0.40). PMID 39988233 ↗

paper Naloxegol was not found to be effective in improving the transit time recovery after elective cardiac surgery. PMID 39988233 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxegol Unknown 25 mg Oral

Indications