Naloxone Block of Low-dose (Analgetic Dose) Ketamine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pain intensity (0-10 Numerical Rating Scale)
研究概览
简要总结
The purpose of this study is to determine whether the analgetic and other effects effect of ketamine are partly mediated through opioid receptors
详细描述
Ketamine er et dissociative anaesthetic closely related with phencyclidine (PCP). Phencyclidine is a non-competitive NMDA-antagonist, and it is assumed that the pharmacodynamic mechanism of action for ketamine is the same. Receptor binding studies shows that ketamine has affinity to many receptor types, including opioid mu and kappa receptors. Ketamine has only about 25 times lower affinity for kappa receptors than for the NMDA-receptor complex. Naloxone is a specific antagonist for opioid receptors and block both mu og kappa receptors. A dose of naloxone 10 times larger than required to block mu receptors is required to block kappa receptors. Experiments with naloxone suggest that ketamine is not a mu agonist, but experiments with sufficient large naloxone doses to block kappa receptors have not been carried out in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind (one making drug solutions) another administrating the drugs
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of norwegian Caucasian origin who needs surgical removal of impacted third molars
排除标准
- •Anamnestic information regarding psychiatric diagnosis regarding mother/father or brother/sister Concommitant medication other than oral contraceptives Hypersensitivity towards NSAID/opioids/study drugs Females with suspected or confirmed pregnancy Lactating females Surgery lasting more than 60 minutes
研究组 & 干预措施
Placebo + Placebo
Saline single bolus dose iv + saline single bolus dose iv
干预措施: Saline (Drug)
Placebo + Ketamine
Saline single bolus dose followed by single bolus dose of ketamine 0.2 mg/kg bw
干预措施: Saline + Ketamine (Drug)
Naloxone + Placebo
Single bolus dose of naloxone 0.2 mg/kg bw followed by single bolus dose of saline
干预措施: Naloxone + Placebo (Drug)
Naloxone + Ketamine
Single bolus dose of ketamine 0.2 mg/kg bw followed by single bolus dose of ketamine 0.2 mg/kg bw
干预措施: Naloxone + Ketamine (Drug)
结局指标
主要结局
Pain intensity (0-10 Numerical Rating Scale)
时间窗: 30 minutes
次要结局
- Subjective measurement of psychotomimetic effects(30 minutes)
- Adverse effects(30 minutes)
研究者
Lasse Ansgar Skoglund
Professor
Oslo University Hospital