Assessment of Drug Liking In Peri-procedural Clinical Settings
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in Drug Liking Rating
研究概览
简要总结
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
详细描述
Specifically, we aim to measure differences in drug liking with a VAS (0 - 100) questionnaire. Additionally, we will monitor neural activity recording a frontal electroencephalogram (EEG) to detect changes in brain signals associated with opioid drug effects. By comparing behavioral and neurophysiological data across treatment and control groups, this study seeks to explore the therapeutic potential of this medication.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- •Candidates who are expected to receive fentanyl up to 3 mcg/kg IBW for their scheduled for surgery or procedure
排除标准
- •Craniofacial abnormalities
- •Known or suspected difficult intubation or mask ventilation
- •Known or suspected need for rapid sequence induction and intubation
- •Allergies or hypersensitivities to droperidol or fentanyl
- •Clinically significant pulmonary disease, such as chronic obstructive lung disease requiring long-term oxygen therapy, or other conditions that, in the study team's judgment, may increase the risk of severe respiratory depression with opioid administration
- •History of long QT syndrome
- •History of Torsades de Pointes
- •History of psychosis
- •History of movement disorders e.g. Parkinson's Disease
- •Past chronic use of anti-psychotics
- •Current use of droperidol, levodopa, lithium, clozapine, metoclopramide, benzodiazepines
- •Current use of opioids
- •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
- •History of pheochromocytoma
- •History of concomitant prolactin-dependent tumors e.g. prolactinoma, breast cancer
- •Pregnancy or nursing
- •Current use of antiemetic medication (i.e., 5HT or dopamine antagonists)
- •Active seizure disorder
- •Active mental health disorders resulting in functional impairment
- •Current use of psychostimulant medications (Adderall)
- •Current use of CNS depressants (e.g., barbiturates, benzodiazepines)
- •Severe renal insufficiency (Stage 4 or 5)
- •Impaired cognitive function
- •Regular Cannabis use (2+ times per week)
- •Current history of substance abuse disorder.
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
Placebo
Participants receive placebo prior to fentanyl administration before their procedure.
干预措施: Placebo (Drug)
Droperidol
Participants receive study drug prior to fentanyl administration before their procedure.
干预措施: Droperidol (Drug)
结局指标
主要结局
Change in Drug Liking Rating
时间窗: One minute before and 1, 3, and 5 minutes after fentanyl administration
Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
次要结局
- EEG band power(From administration of the study drug to about 1 hour after.)
- Change in Sedation Rating(One minute before and 1, 3, and 5 minutes after fentanyl administration)
研究者
Patrick Purdon
Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University