NCT04433390|CompletedPhase 3
Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery
TRANSIT
Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
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TRANSIT
Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
Sponsor study identifier
interventional
305
1 country
1
Study Start
October 14, 2020
Actual (reported)Primary Completion
January 28, 2022
Actual (reported)Study Completion
March 3, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 3, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2020
Actual (reported)June 16, 2020
Actual (reported)October 14, 2020
Actual (reported)January 28, 2022
Actual (reported)March 3, 2022
Actual (reported)Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery
Time (hour) to transit recovery after cardiac surgery
5 days
Incidence of digestive complications
30 days
Evaluate the effect of the administration of Naloxegol on respiratory complications
30 days
Evaluate the effect of the administration of Naloxegol on infectious complications
30 days
Verify the effectiveness of analgesia
day 1, day2, day3
Compare the length of hospital stay
30 days
naloxégol tablet by oral route
inert tablet by oral route
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.
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.
CMC Ambroise Paré
Neuilly-sur-Seine, Neuilly Sur Seine, 92200, France
Laghlam D, Gibert H, Merzoug M, Leclerc D, Coroyer L, Estagnasie P, Squara P, Nguyen LS, Geri G. Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101498. doi: 10.1016/j.accpm.2025.101498. Epub 2025 Feb 21.
305 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
October 14, 2020
Actual (reported)Ancillary Effects of Oral Naloxegol (Movantik)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 28, 2022
Actual (reported)Study Completion
March 3, 2022
Actual (reported)Last Updated
May 20, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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