Sevoflurane's Effect on Neurocognition Study
概览
- 阶段
- 早期 1 期
- 干预措施
- Peripheral Nerve Stimulation
- 疾病 / 适应症
- Anesthesia
- 发起方
- Keith M Vogt
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- functional magnetic resonance imaging activation in response to experimental tasks
- 状态
- 已完成
- 最后更新
- 17天前
概览
简要总结
The purpose of this study is to determine the effects of acute pain on long-term memory and conditioned physiologic responses in the presence and absence of low dose sevoflurane. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will occur over 2 visits and involves no long-term follow up.
详细描述
This is a non-randomized, clinical trial study of healthy volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of inhalational sevoflurane on pain processing and cognitive function. Sedative doses of sevoflurane will be targeted, and steady-state end-tidal (expired) concentrations achieved, while subjects perform a pain and memory cognitive task. At both no-drug baseline and the targeted doses, task and resting-state functional magnetic resonance imaging (MRI) scans will be acquired, and this data will be analyzed subsequently for task-related brain activity(from pain processing and memory formation) and functional connectivity. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of inhalational sevoflurane in the context of painful stimulation. The investigators propose to complete the following 3 Aims, at a sedative dose of Sevoflurane, compared to no-drug baseline, using functional MRI: Aim 1: Determine how the brain response to acute pain stimulation is modulated by sevoflurane. It is anticipated that sevoflurane will correlate to decreased activation in both somatosensory (thalamus, insula, primary somatosensory/motor) and affective (anterior cingulate) components of the pain processing brain areas. Aim 2: Determine how memory encoding is modulated by sevoflurane, in the context of periodic painful stimulation. It is anticipated that sevoflurane will correlate to decreased activation in both the explicit memory (hippocampus, parahippocampus) and associative learning (amygdala, anterior cingulate) brain systems. Aim 3: Determine the neural effects of inhalational sevoflurane on brain connectivity both at rest and during the combined pain and memory task performance. It is anticipated that hypothesize that sevoflurane will cause widespread dose-dependent decreases in long-range functional connectivity between brain areas known to be involved in pain processing and to the default mode network, and that this connectivity will differ between the resting (task-free) and periodic pain states.
研究者
Keith M Vogt
Associate Professor
University of Pittsburgh
入排标准
入选标准
- •Adults, age 18-59, who are native English speakers with at least a high school education
- •have normal hearing and memory
- •be of normal body-weight
- •be generally healthy (free from significant chronic disease)
- •have none of the specific
排除标准
- •have a valid email address and valid phone number throughout the study
- •anticipate ability to participate in all visits required for the phase of the study in which they are enrolled
- •Exclusion Criteria:
- •being pregnant or attempting to conceive
- •having a body mass index (BMI) \> 35
- •having significant memory impairment or hearing loss
- •having sleep apnea
- •having chronic pain or frequently taking pain medication (including tramadol)
- •having any severe or poorly-controlled medical problem (hypertension, diabetes)
- •having neurologic or psychiatric disease, including anxiety, and depression
研究组 & 干预措施
Sevoflurane+Pain
Single-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions.
干预措施: Peripheral Nerve Stimulation
Sevoflurane+Pain
Single-arm study. All subjects receive sevoflurane and painful electric nerve stimulation, as described in the interventions.
干预措施: Sevoflurane
结局指标
主要结局
functional magnetic resonance imaging activation in response to experimental tasks
时间窗: Visit 1: Immediate; average activity, calculated from each task scan
Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of each type of experimental item (memory only, pain only, and memory+pain), creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane.
Functional connectivity
时间窗: Visit 1: Immediate; brain activity captured in data acquired across entire 6-8 minute scan.
Whole-brain functional connectivity will be determined in each condition (no-sevoflurane, low-dose, and high-dose). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no sevoflurane to low concentration sevoflurane sevoflurane.
次要结局
- Explicit memory performance(Visit 2: 24-hrs post-learning experiment)