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临床试验/NCT02247024
NCT02247024已完成不适用

Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
2
主要终点
Pupillary reflexes

研究概览

简要总结

Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain intensity, sedation score, and other side effects of opioids. Measurements of the concentration of opioids and their active metabolites in blood.

详细描述

Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size and reaction are also influenced by drugs, where opioids result in miosis, an effect that is not considered to be influenced by opioid tolerance. However, cancer patients on high-dose opioids do not always present small pupil size.

We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids. In addition to pupil size measurements under standard room light conditions, two pupil size reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and the reflex dilation during a standardized noxious stimulus. On the same time we will assess pain intensity, sedation score, and other side effects of opioids while measuring the concentration of opioids and their active metabolites in blood. In addition we will register all concomitant medication that also might influence pupil size and reaction. Patients on more than 60 morphine equivalents pr day will be included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In-patients and out-patients at Oslo University Hospital with cancer pain who have use opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs) at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral morphine equivalents pr day

排除标准

  • Patients who have undergone eye-surgery that may influence pupillary reflexes
  • Patients on local medication that may influence pupillary reflexes
  • Patients with amyloidosis, multiple sclerosis, Horner's syndrome, or ongoing migraine attack
  • Patients with brain tumor

结局指标

主要结局

Pupillary reflexes

时间窗: One year

Dynamic pupillometry

次要结局

  • Opioid and metabolite concentration(One year)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulf Kongsgaard

Professor

Oslo University Hospital

研究点 (2)

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