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COMPLETED
NCT04433390
PHASE3

Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

Sponsor: CMC Ambroise Paré

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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