2024-514307-34-01招募中2 期
A randomized, double-blind parallel group study to investigate propofol injection pain compared with placebo in healthy adult male and female participants. (PropPain)
Oslo University Hospital HF1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • Proportion of participants with VAS≥30 mm (0-100mm)
研究概览
简要总结
• Determine proportion of participants experiencing significant pain by intravenous injection of propofol or placebo
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
- •The participant is overtly healthy as determined by medical evaluation including medical history and physical examination
- •Participant is ≥ 18 and < 50 years of age
- •Highly sensitive urine pregnancy test is negative for WOCBP
- •The participant must give a signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Known allergy or intolerance to the study intervention propofol
- •Known neurological illnesses (eg epilepsy)
- •Known allergy or intolerance to eggs, soya or peanuts
- •BMI is <16 and ≥30
- •Use of analgesics or alcohol the last 24 h before study intervention
- •The participant is breastfeeding
- •The participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)
- •Participation in other clinical studies within the last two months before study intervention
- •Not meeting the rules of fasting according to the protocol
- •Any condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures.
结局指标
主要结局
• Proportion of participants with VAS≥30 mm (0-100mm)
• Proportion of participants with VAS≥30 mm (0-100mm)
次要结局
- • • Max electronic Visual Analog Scale (VAS) pain (0-100 mm)
- • Max Numeric Rating Scale (NRS) pain (0-10)
- • Time (seconds) to max electronic Visual Analog Scale (VAS) pain
- • Area under the curve (AUC) 0-1 min, 1-2 min, 2-3 min
- • Area under the curve VAS≥30 (AUCVAS≥30) 0-1 min, 1-2 min, 2-3 min
- • Curve shape of electronic Visual Analog Scale (VAS) pain (0-100 mm) by description of the curve (number of peaks)
- • Richmond Agitation-Sedation Scale (RASS)
研究者
Marianne Myhre
Scientific
Oslo University Hospital HF
研究点 (1)
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