2024-517234-18-00招募中1 期
Nitrous oxide detection - A study in healthy volunteers to help victims of nitrous oxide related crimes
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time from end of inhalation of study medication to N2O-concentration in blood is no longer statistically significantly increased in the active treatment group compared to the placebo group
研究概览
简要总结
The primary objective is to investigate blood concentrations of N2O after exposure and determine how long N2O can be detected after exposure.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18-65 years
- •Informed, written consent
- •Able to understand Danish
- •Participants willing and able to use safe contraception for 24 hours day after gas exposure
排除标准
- •Psychiatric and neurological: • Current or previous substance abuse, N2O abuse or alcohol abuse • A psychiatric disorder that requires medical treatment, incl. major depression • A diagnosis of epilepsy • Symptoms of peripheral neuropathy Cardiopulmonary: • Displaying symptoms of pneumothorax, pneumopericardium, bullous emphysema, gas emboli or severe cranial trauma. • Recent history of coronary artery bypass grafting (CABG) operation with extra corporeal membrane oxygenation (ECMO). • Uncontrolled asthma defined by occurrence of asthma symptoms within the last month prior to inclusion. Anesthesiological: • History of adverse reactions to anaesthesia. • Previous allergic or adverse reaction to N2O • Facial abnormalities that cause a participant to be unable to fit a nasal cannula intended for gas delivery. Occupational: • History of diving within 2 days • Inability to refrain from diving for 2 days following the experiment • Work environmental exposure to N2O • Intake of N2O within the last 3 months Interactions with medications: • Treatment with methotrexate • Treatment with benzodiazepines, opioids, or another CNS-depressant medicinal product • Treatment with physician prescribed vitamin B12 • Recent intraocular injection of gas. Gastroentestital: • Vitamin B12 deficiency • Participant with severely dilated intestines. • History of impaired hepatic or renal function Gynecological/ obstetrical: • Pregnant and breastfeeding women (Fertile women (defined as amenorrhea for less than 12 months) must have a negative HCG pregnancy test prior to intake of the trial medication)
结局指标
主要结局
Time from end of inhalation of study medication to N2O-concentration in blood is no longer statistically significantly increased in the active treatment group compared to the placebo group
Time from end of inhalation of study medication to N2O-concentration in blood is no longer statistically significantly increased in the active treatment group compared to the placebo group
次要结局
- Time until N2O-concentration in exhaled breath is no longer statistically significantly increased in the active treatment group compared to the placebo group
- Time until N2O-concentration in oral fluid and urine is no longer statistically significantly increased in the active treatment group compared to the placebo group.
- Time until N2O screening breathalyzer is no longer capable of N2O detection.
- Time until the longest detectable possible biomarker in blood or urine is no longer up- or downregulated in the active treatment group compared to the placebo group.
- Time until formiminoglutamic acid is no longer statistically significantly increased in the active treatment group compared to the and placebo group.
- Verifying that concentration of N2O and possible biomarkers can detected by routine screening at Department of Forensic Medicine, Aarhus University.
研究者
Department of Forensic Medicine, Aarhus University
Scientific
Aarhus Universitet
研究点 (1)
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