Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery
研究概览
简要总结
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.
详细描述
Digestive complications following cardiac surgery, such as paralytic ileus and Ogilvie syndrome, are frequent and worsen the prognosis of patients. They pose a real problem of care in intensive care, inducing morbidity and mortality, extended hospital stay and a significant post-operative cost.
Few treatments are effective to reduce transit recovery time, except the neostigmine which has a serious side effects including cardiac ones.
During cardiac surgery, opioid treatments are frequently used to relieve the pain like sternotomy pain.
The pharmacologic effect of opioid induces the postoperative uleus. Opioid receptors are distributed in the central nervous system, where they are involved in the perception of pain, and in the peripheral nervous system, especially in the mesenteric nervous system, where they regulate intestinal peristalsis.
Morphine receptors antagonist are a target for prevention and treatment of post operative ileus syndrome such as alvimopan and naloxone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the nurse giving the treatment is not the outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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.
排除标准
- •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.
研究组 & 干预措施
Placebo group
inert tablet by oral route
干预措施: inert tablet (Drug)
Naloxegol group
naloxégol tablet by oral route
干预措施: Naloxegol (Drug)
结局指标
主要结局
Evaluate the effect of perioperative naloxegol administration on the duration of postoperative ileus after cardiac surgery
时间窗: 5 days
Time (hour) to transit recovery after cardiac surgery
次要结局
- 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)
- Compare the length of hospital stay(30 days)
- Compare the length of ICU stay(30 days)
- Verify the effectiveness of analgesia(day 1, day2, day3)