NCT06699953Enrolling By Invitation不适用
Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Source Localization of Fentanyl EEG Signature
研究概览
简要总结
The goal of this study is to characterize an electroencephalogram (EEG) biomarker for fentanyl and understand where this signal is coming from in the brain. The investigators also aim to understand how this EEG biomarker is connected to patient perception to drug liking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or above (male and female)
- •American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- •Candidates scheduled for general surgical procedures under general anesthesia and receive fentanyl for surgery
排除标准
- •Craniofacial abnormalities
- •Known or suspected difficult intubation or mask ventilation
- •Known or suspected need for rapid sequence induction and intubation
- •Body mass index above 45 kg/m2
- •Allergies to fentanyl
- •History of obstructive sleep apnea requiring CPAP
- •History of obstructive or restrictive lung disease
- •Opiate use within 24 hours
- •History of opiate abuse within the last 3 years
- •Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
- •MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
结局指标
主要结局
Source Localization of Fentanyl EEG Signature
时间窗: 15 minutes prior to surgery
The investigators will perform high density electroencephalogram to estimate the power and source localization of canonical (delta, theta, alpha, gamma and beta) bands power to determine the likely generators for the fentanyl EEG signature.
次要结局
- Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration(15 minutes prior to surgery)
- Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature(15 minutes before the surgery)
研究者
Patrick Purdon
Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University
研究点 (2)
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