Evaluation of Antihyperalgesic and Analgesic Effects of 35% Nitrous Oxide in a Human Model of Electrically Evoked Hyperalgesia and Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hyperalgesia
研究概览
简要总结
Evaluation of the effects of 35%/15%/50% N2O/N2/O2 mixtures on the area of hyperalgesia induced by remifentanil in the CCES (Continuous Cutaneous Electrical Stimulation) model in 20 healthy volunteers.
The duration of participation for each volunteer is expected to be around 9 weeks with the performance of 4 experimental session 2 weeks apart.
The selection visit will last half a day; each experimental session will last half a day; the study end will last 2 hours maximum.
详细描述
Single site, exploratory, comparative, double-blind, randomised, cross-over study. Three physicians will be involved in the conduct of this study:
- Physician 1 will include and randomise the subjects, prepare and administer the study products (namely Investigational Medicinal Products (IMPs)) in an open manner and will assess subject safety.
- Physician 2, kept IMP blinded, will perform all evaluation measurements and sedation assessments during all experimental sessions. Physician 2 will always be the same person throughout the whole study period.
- Physician 3 will be available if needed to reinforce subject safety
Design: A group of 20 assessable subjects who will undergo 4 randomised experimental sessions of CCES on 4 separate study days, 2 weeks apart preceded by a 2 week period between selection and first experimental session and followed by a 1 week period between last experimental session and study end.
After the selection visit, each visit corresponds to one of the 4 experimental sessions named A, B, C, D differing by the gas mixture inhaled and the intravenous medicine administered.
The order of these experimental sessions A, B, C, D, will be assigned according to a pre-established list that the investigator will not know.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian healthy male
- •Able to feel a distinct pin-pick sensation on normal skin
- •Subject willing and able to complete the requirements of this study
- •Written informed consent signed prior to any study related procedures
排除标准
- •History of any past or current renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine haematological, neurological, psychiatric disease or other disorders
- •Any significant history of allergic disease
- •Acute skin disease, lesions, acute sunburn, extensive tattoos or scars
- •Donation of blood within the previous 3 months
- •participation in any other clinical study within the previous 4 weeks.
研究组 & 干预措施
Tested drug
Remifentanil at 0.1 µg/kg/min Tested drug (N2O 35%): 35%/15%/50% N2O/N2/O2
干预措施: Nitrous Oxide (Drug)
Gas Active control
Remifentanil at 0.1 µg/kg/min Gas active control (N2O 50%):50%/50% N2O/O2
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Hyperalgesia
时间窗: at T0, T10, T25, T40, T55, T70, T95, T110, T125, T140 and T155 minutes at each experimental session which will last half day
\- Hyperalgesia will be assessed by using a metal rod,(in unit cm).
次要结局
- transcutaneous oxygen saturation(From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day)
- respiration rate(From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day)
- systolic and diastolic blood pressures(From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day)
- Heart rate(From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day)
- sedation score(From T0 to T160 minutes, at 5 minute intervals at each experimental session which will last half day)