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临床试验/NCT00504894
NCT00504894终止4 期

Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年3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
终止
入组人数
60
试验地点
1
主要终点
Blood-oxygen-level-dependent Significant Activation Cluster

研究概览

简要总结

This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general community. It involves doing a set of simple memory tests while inside a fMRI machine. The subject is given a very low dose of an anesthetic drug intravenously while in the scanner. The subject then sees a sequence of pictures on a screen, and presses a button if they remember seeing the picture before. While this is happening, the scanner will be capturing images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will be altered by intravenous anesthetics such that suppression of hippocampal and amygdala activities will be dissociable. This dissociation pattern will be different between the drugs propofol and thiopental.

详细描述

Background: Subclinical doses of propofol produce anterograde amnesia, characterized by an early failure of memory consolidation. It is unknown how propofol affects the amygdala-dependent emotional memory system, which modulates consolidation in the hippocampus in response to emotional arousal and neurohumoral stress. We present an event-related functional magnetic resonance imaging study of the effects of propofol on the emotional memory system in human subjects.

Methods: Sixty healthy subjects were randomized to receive propofol, at an estimated brain concentration of 0.90 μgml-1, thiopental, at an estimated brain concentration of 3.0 μgml-1, or placebo. During drug infusion, emotionally arousing and neutral images were presented in a continuous recognition task, while blood-oxygen-level-dependent activation responses were acquired. After a drug-free interval of 2 h, subsequent memory for successfully encoded items was assessed. Imaging analysis was performed using statistical parametric mapping and behavioural analysis using signal detection models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age b/w 18 and 50
  • right-handed
  • minimum of high school education
  • fluent in English
  • normal vocabulary

排除标准

  • any significant medical/psychiatric comorbidity
  • deficit in vision or hearing that would impede the study
  • allergies to any of the study drugs, to soybeans, or eggs.
  • history of head trauma
  • family history of major psychiatric illness
  • body mass index > 30 kg/m2
  • claustrophobia
  • prior exposure to IAPS pictures
  • pregnancy
  • permanent metal objects anywhere in the body
  • a personal/family history of any porphyria

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo given in low dose to gauge subject's responses to visual stimuli.

干预措施: Placebo (Drug)

Propofol

Active Comparator

Propofol given at 0.90 μgml-1 to gauge subject's responses to visual stimuli.

干预措施: Propofol (Drug)

Thiopental

Active Comparator

Thiopental given at 3.0 μgml-1 to gauge subject's responses to visual stimuli.

干预措施: Thiopental (Drug)

结局指标

主要结局

Blood-oxygen-level-dependent Significant Activation Cluster

时间窗: for 90 minutes after the drug/placebo was commenced

Three anatomical regions for which there was an a priori mechanistic hypothesis were assessed using standard small volume correction: (i) the amygdala, bilaterally; (ii) the hippocampus, bilaterally; and (iii) the parahippocampus, bilaterally. Using single-tailed t tests, a priori regions were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons in the hypothesized anatomical region. For non-hypothesized regions outside the medial temporal lobe, findings were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons across the whole brain. Clusters containing voxel maxima at these thresholds are reported.

次要结局

  • Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory(for 90 minutes after the drug/placebo was commenced)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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