The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Respiratory depression
研究概览
简要总结
This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.
详细描述
Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents.
The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Subjects must be aged 18 years or above at baseline
- •Diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic.
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
排除标准
- •Allergy/sensitivity to naloxone
- •Female subjects who are pregnant or breast-feeding.
- •Subjects who have received any other investigational agent within 2 months
- •Subjects taking anticonvulsant medications for epilepsy
- •Subjects who have a cardiac arrhythmia with an uncontrolled rate
- •Subjects who have a history of chronic opioid use / chronic pain
- •Any contraindication to intrathecal injection eg coagulopathy
- •Documented history of obstructive sleep apnoea
- •Treating clinician feels not in the patients best interests to be randomised
研究组 & 干预措施
Naloxone
The naloxone arm of the study will receive naloxone at a rate of 5mcg/kg/hr which equates to 0.25ml/kg/hr. Each 1 ml ampoule of solution contains 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate.
Excipients: each 1ml contains 3.55mg sodium. This will be diluted to a concentration of 20mcg/ml with 0.9% NaCl. Presented as solution for injection or infusion. Clear colourless sterile solution.
干预措施: Naloxone (Drug)
Saline
The placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.
干预措施: Placebo (Drug)
结局指标
主要结局
Respiratory depression
时间窗: within 16 - 24 hours of participation
次要结局
- Measure of occurrence of pain(within 16 - 24 hours of participation)
- Requirement for rescue analgesia(within 16 - 24 hours of participation)
- Nausea/Vomiting(within 16 - 24 hours of participation)
- Pruritus(within 16 - 24 hours of participation)