Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial

IF 3.7 3区医学 Q1 ANESTHESIOLOGY

Anaesthesia Critical Care & Pain Medicine Pub Date : 2025-02-21 DOI:10.1016/j.accpm.2025.101498

Driss Laghlam , Hadrien Gibert , Messaouda Merzoug , Didier Leclerc , Lucas Coroyer , Philippe Estagnasie , Pierre Squara , Lee S. Nguyen , Guillaume Geri

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引用次数: 0

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 16^th, 2020.

查看原文本刊更多论文

纳洛格尔对心脏手术患者转运恢复的影响：一项随机、双盲、安慰剂对照试验。

背景：麻痹性肠梗阻是心脏手术后的主要围手术环境，影响患者预后。方法：我们进行了一项单中心、随机、双盲、安慰剂对照的3期研究。我们招募了18岁以上接受非紧急心脏手术的患者。符合条件的患者以相同的比例随机分配到纳洛西戈或匹配的安慰剂组。参与者被随机分配到以下一组：(1)纳洛西格尔12.5毫克，指数手术前2小时，然后纳洛西格尔25毫克，每天一次，或(2)匹配安慰剂。服用纳洛西格尔或安慰剂长达5天，如果患者有过境恢复则永久停止。主要终点为心脏手术后胃肠运输恢复时间，定义为麻醉诱导至第一次排便的时间(h)。结果：在2020年10月14日至2022年1月28日期间，299名参与者被纳入修改意向治疗疗效分析（纳洛西戈组151名，安慰剂组148名）。平均年龄62±10.1岁，男性占81.6%，高血压占53.8%，糖尿病占20.7%，中位体重指数为25.9 (IQR 23.7 ~ 29.4) kg/m2。纳洛西格尔组和安慰剂组的过境恢复时间无差异（76.0,[IQR 69.3-93.5] vs. 78.3, [IQR 70.0-95.8]小时，p值= 0.40）。我们没有观察到两组之间预先指定的次要疗效有任何差异。两组患者的疼痛程度和一些严重不良事件没有差异。结论：纳洛戈洛对心脏择期手术后转运时间恢复无明显作用。该试验已于2020年6月16日在clinicaltrials.gov （NCT04433390）上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Anaesthesia Critical Care & Pain Medicine ANESTHESIOLOGY-

CiteScore

6.70

自引率

5.50%

发文量

150

审稿时长

18 days

期刊介绍： Anaesthesia, Critical Care & Pain Medicine (formerly Annales Françaises d''Anesthésie et de Réanimation) publishes in English the highest quality original material, both scientific and clinical, on all aspects of anaesthesia, critical care & pain medicine.