A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation
试验速览
- 阶段
- 2 期
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Time to substantial bowel movement
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.
详细描述
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.
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
- Double (Participant, Investigator)
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
- •Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
- •Admitted to Bethesda North TriHealth Hospital CVICU post-surgery
排除标准
- •Medically unstable
- •Cognitive deficits that impair the patient's ability to understand the informed consent
- •Language barriers
- •Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction
- •Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil
- •Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals
- •Conditions that present an increased risk of bowel perforation (as determined by the physician)
- •Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician
研究组 & 干预措施
Naloxegol
naloxegol 25 mg pill
干预措施: Naloxegol 25 MG (Drug)
Placebo
placebo pill
干预措施: Placebo pill (Other)
结局指标
主要结局
Time to substantial bowel movement
时间窗: Post-operative day 5
Time to bowel movement of Type 2 or higher on the Bristol stool chart
次要结局
- Rescue medications(Post-operative day 5)