Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Morphine Area under the curve (AUC)
研究概览
简要总结
The main objective of the trial is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery
详细描述
The purpose of the experiment is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is primarily done by investigating systemic exposure of morphine in a cohort of patients undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same patients by registering pain during rest and activity, side effects and the degree of sedation at appropriate time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned Colectomy / Hemicolectomy, sigmoid resection, rectal resection or abdominal perianal amputation of the rectum with stoma, good general health (ASA 1 -2), Informed consent given, Age 18-90 years and BMI 18,5 - 35kg/m².
排除标准
- •Abdominoperineal resection (APR) - ad modum Holm (abdominal perianal amputation of rectum with stoma)
- •Daily use of opioids
- •Indicator for the use of an epidural catheter
- •Alcohol abuse
- •Hypersensitivity for morphine
- •A known serious disease (Terminal cancer, severe dementia, significant heart, liver, lung or renal failure or severe psychiatric disease)
- •Women of childbearing age who do not use safe contraception
- •Women who are breastfeeding
- •Pregnant women
研究组 & 干预措施
Morphine
Intravenous morphine (0,15 mg/kg) will be given as a single dosis at the end of the surgery followed by morphine administrated by patient-controlled analgesia (PCA) as single boluses (0,04mg/kg)
干预措施: Morphine (Drug)
结局指标
主要结局
Morphine Area under the curve (AUC)
时间窗: Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus
Difference in morphine AUC due to patient OCT1 status
次要结局
- Morphine effect(After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.)
研究者
Ida Kuhlmann
MD, phd student
University of Southern Denmark