Effectiveness of Nefopam for Thermoregulation During Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- V1
研究概览
简要总结
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia
详细描述
Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering.
Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.
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
- Double (Participant, Investigator)
盲法说明
Blinded drug containers.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteers ages 18-40
排除标准
- •history of alcohol or drug abuse
研究组 & 干预措施
Nefopam low dose
Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.
干预措施: Nefopam Low dose (Drug)
Nefopam high dose
Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.
干预措施: Nefopam High dose (Drug)
结局指标
主要结局
V1
时间窗: three hours of infusion
Volume of distribution 1
V2
时间窗: three hours of infusion
Volume of distribution2
CLel
时间窗: three hours of infusion
Clearance
CLdist
时间窗: three hours of infusion
Clearance distribution
次要结局
未报告次要终点