Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain: a Placebo-controlled Study in Healthy Male Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- AUC of the grand averaged mean differences between ERPs elicited by target and non-target words
研究概览
简要总结
This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing
详细描述
Ketamine is a unique anesthetic with neural effects that are distinct from more commonly-used γ-aminobutyric acid agonists. Evidence suggest that analgesic effect of ketamine is primarily related to the affective than the sensorial aspects of pain interpretation. The investigators investigated whether ketamine, a noncompetitive NMDA antagonist, would modify the perceived emotional valence of pain-related words when compared to non-pain-related ones in healthy volunteers. Using a single session double-blind parallel placebo-controlled design, 24 healthy volunteers were randomized to receive intravenous S-ketamine (n=12) or placebo (n=12). During infusion (plasmatic target of 60 ng/ml), the effects of ketamine were recorded using EEG and oddball behavioral data was monitored. Evoked potentials (N200 and P300 components) were recorded during performance of a semantic written word oddball task containing pain-related (targets) and non-pain-related words (standards). Expected results: The findings of this study can help in the understanding of neurophysiologic mechanisms involved in ketamine's effects both in psychiatric diseases as in the treatment of postoperative acute and chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male healthy subjects with higher education level
排除标准
- •do not understand Portuguese language
- •obese patients (BMI > 27 kg/m2)
- •use of NSAID, steroids, analgesics, anticonvulsant drugs, as well as alpha and beta-blockers
- •score ≥ 13 on Beck II Questionnaire
- •sleep deprivation in the night before evaluation
研究组 & 干预措施
Group S-Ketamine
S-Ketamine will be diluted in normal saline and administrated in a target controlled infusion using an infusion pump to obtain a plasma target of 60 ng/ml according to Domino's model. Infusion will start during the interval between the 3rd and 4th blocks of the task.
干预措施: Ketamine (Drug)
Group Placebo
A previously prepared identical solution containing only normal saline will be infused at the same infusion rates of group ketamine.
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of the grand averaged mean differences between ERPs elicited by target and non-target words
时间窗: up to 60 min
EEG will be recorded during all task time. The main outcome will be the area under de curve (AUC) of the grand averaged mean differences between event-related potencials (ERPs) elicited by target and non-target words at 100-200, 300-500 and 800-900 ms after stimulus presentation for parietal electrophysiological signal (Pz). The ERPs represent the averaged voltage of several trials.
次要结局
- Word ratings related to the semantic valence(up to 60 min)
- Response times (behavioural oddball data)(up to 60 min)
