NCT01419405已完成4 期
Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.
详细描述
Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).
Side effects such as nausea and sedation were registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers,
- •> 18 yrs < 55 yrs,
- •negative pregnancy test
排除标准
- •Pregnancy,
- •known heart-, lung- or liver disease,
- •kidney failure/peptic ulcers,
- •use of liver enzyme-inducing medications,
- •known allergy against the medications used in the trial,
- •use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,
- •body weight > 100 kg or 30% deviation from normal weight,
- •participant in other studies during the last 2 months,
- •individuals who do not master Norwegian language
研究组 & 干预措施
Pregabalin/placebo
Experimental
干预措施: Pregabalin (Drug)
placebo/remifentanil
Active Comparator
干预措施: Remifentanil (Drug)
placebo/placebo
Placebo Comparator
干预措施: sugar pill, saline infusion (Drug)
Pregabalin/Remifentanil
Experimental
干预措施: Pregabalin (Drug)
Pregabalin/Remifentanil
Experimental
干预措施: Remifentanil (Drug)
结局指标
主要结局
Pain intensity
时间窗: 123 sec x 4
Pain was caused by Cold Pressure Test
次要结局
- Ventilatory function(10 min x 4)
- Cognitive function(4 min x 4)
研究者
研究点 (1)
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