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Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery
Sponsor: CMC Ambroise Paré
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.
Official title: Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
305
Start Date
2020-10-14
Completion Date
2022-03-03
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
Naloxegol
one naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
inert tablet
one inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
Locations (1)
CMC Ambroise Paré
Neuilly-sur-Seine, Neuilly Sur Seine, France