Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

NCT04433390 | Completed Phase 3

• 1 other identifier: 2019-09
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Ileus (Post Cardiac Surgery Constipation)

Keywords

Opioid induced constipation; cardiac surgery; transit recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Naloxegol group

EXPERIMENTAL

naloxégol tablet by oral route

Drug: Naloxegol

Placebo group

PLACEBO COMPARATOR

inert tablet by oral route

Drug: inert tablet

Interventions

Naloxegol DRUG

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.

Naloxegol group

inert tablet DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

Neuilly-sur-Seine, Neuilly Sur Seine, 92200, France

Location

Related Publications (1)

• 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.

  PMID: 39988233 DERIVED

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the nurse giving the treatment is not the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: October 14, 2020
• Primary Completion: January 28, 2022
• Study Completion: March 3, 2022
• Last Updated: March 8, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)