Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial - 18/03/25
, Hadrien Gibert b, Messaouda Merzoug c, Didier Leclerc b, Lucas Coroyer a, Philippe Estagnasie a, Pierre Squara a, Lee S. Nguyen a, Guillaume Geri aHighlights |
• | Management of paralytic ileus remains challenging after cardiac surgery. |
• | Mean transit time recovery was 76.8 (69.9−94.9) h after cardiac surgery. |
• | Orally taken Naloxegol did not improve the transit time recovery. |
• | Naloxegol did not reduce digestive complications after cardiac surgery. |
Abstract |
Background |
Paralytic ileus is a major surrounding after cardiac surgery and worsens patients’ prognosis.
Methods |
We conducted a single-centre, randomized, double-blind, placebo-controlled phase 3 study. We enrolled patients over 18 years old who underwent non-urgent cardiac surgery. Eligible patients were randomly allocated to Naloxegol or matching placebo in an equal ratio. The participants were randomly assigned to one of the following groups: (1) Naloxegol 12,5 mg 2 h before index surgery, and then Naloxegol 25 mg once daily, or (2) matching placebo. Naloxegol or placebo was administered for up to 5 days and permanently stopped if the patient had transit recovery. The primary endpoint was the time of postoperative gastrointestinal transit recovery after the index cardiac surgery, defined as the time in hours between the anaesthetic induction and the emission of the first significant stool.
Results |
Between October 14, 2020, and January 28, 2022, 299 participants were included in modified intention-to-treat efficacy analyses (151 in the Naloxegol group and 148 in placebo). The mean age was 62 ± 10.1 years old, 81.6% were male, 53.8% had hypertension, 20.7% had diabetes mellitus, and the median body mass index was 25.9 (IQR 23.7−29.4) kg/m2. Time-to-transit recovery did not differ between Naloxegol group and placebo (76.0, [IQR 69.3−93.5] vs. 78.3, [IQR 70.0−95.8] h, p value = 0.40). We did not observe any difference in the prespecified secondary efficacy between both groups. Pain levels and a number of serious adverse events were not different in both groups.
Conclusions |
Naloxegol was not found to be effective in improving the transit time recovery after elective cardiac surgery.
The trial was registered on ClinicalTrials.gov (NCT04433390) on June 16th, 2020.
Le texte complet de cet article est disponible en PDF.Keywords : Cardiac surgery, Cardiopulmonary bypass, Gastrointestinal complications, Naloxegol, Pain, Paralytic ileus
Plan
Vol 44 - N° 2
Article 101498- avril 2025 Retour au numéro
Article précédent
- Time on the waiting list is an independent risk factor for day-90 mortality after lung transplantation
- Enora Atchade, Vincent Bunel-Gourdy, Nathalie Zappella, Sylvain Jean-Baptiste, Alexy Tran-Dinh, Sébastien Tanaka, Brice Lortat-Jacob, Arnaud Roussel, Pierre Mordant, Yves Castier, Hervé Mal, Christian De Tymowski, Philippe Montravers
- Efficacy and safety of topical lignocaine anesthesia in improving patient satisfaction after endobronchial ultrasound–guided transbronchial needle aspiration under general anesthesia: A randomized controlled trial
- Sen Zhang, Wannan Chen, Jian Wang, Changhong Miao, Hao Fang, Chao Liang
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?