Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

• Status: Recruiting
• Trial end date: 2022-11-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CMC Ambroise Paré
• Treatments: Naloxegol

Criteria

Inclusion Criteria:

• > 18 years old,

• Undergoing cardiac surgery with cardiopulmonary bypass,

• For women of child bearing potential without contraception, beta-HCG negative result

• Having signed a written informed consent form,

• Affiliation to the social security system.

Exclusion Criteria:

• Allergy or known hypersensitivity to Naloxegol or any of the excipients or any other opioid antagonist

• Pregnant or breastfeeding women

• Severe hepatic failure, history of cirrhosis

• Moderate or severe renal failure (GFR<60ml/min)

• Concomitant treatment with a strong cytochrome P450 3A4 inhibitor

• History of acute gastro-intestinal obstruction known or suspected

• History of digestive arteritis

• Clinically relevant alteration of the blood-brain-barrier

• Cancer with increased risk of gastro-duodenal perforation

• Disorder that could alter the integrity of the gastrointestinal lining

• Regular treatment with laxative drugs

• Concomitant treatment with methadone

• Patient unable to take a drug by oral route

• Patient under protection of the adults (guardianship, curators or safeguard of justice),

• Patient included or planning to be included in another research protocol relating to medications.