Experimental hypothermia using cold ambient temperature and drug-induced inhibition of shivering in awake, healthy volunteers: a crossover, double blinded trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Temperature at termination. The experiment for a participant will be terminated if temperature reaches 35C or active cooling exceeds 3 hours or other reasons (technical problems, terminated by participant). Temperature will be measured at all timepoints. Temperature measurements by Body CAP capsule at all time points will function as backup.
研究概览
简要总结
We aim to reduce core temperature by lowering ambient temperature utilizing a climate chamber and administrating meperidine and buspirone to inhibit shivering. We will measure difference in temperature (active drug vs. placebo) at termination.
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
- •Participant must be over 18 and under 40 years of age at the time of signing the informed consent.
- •Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health-report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the IMPs used.
- •BMI under 30 kg/m2
- •Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidin, klorpromazine, fenytoin, erythromycin, itrakonazol, platelet inhibitors, apomorfin, alcohol (during the trial period) or other opioids (during the trial period). A history of drug dependency.
- •Recent head injury, increased ICP, seizures or epilepsy.
- •Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, Myasthenia gravis. Previous abdominal surgery. History of cold injuries or frostbites.
- •Planned MRI the next two days after ingestion of temperature capsule.
结局指标
主要结局
Temperature at termination. The experiment for a participant will be terminated if temperature reaches 35C or active cooling exceeds 3 hours or other reasons (technical problems, terminated by participant). Temperature will be measured at all timepoints. Temperature measurements by Body CAP capsule at all time points will function as backup.
Temperature at termination. The experiment for a participant will be terminated if temperature reaches 35C or active cooling exceeds 3 hours or other reasons (technical problems, terminated by participant). Temperature will be measured at all timepoints. Temperature measurements by Body CAP capsule at all time points will function as backup.
次要结局
- Time from initiation of cooling to termination. Esophageal temperature at all time points. Temperature measurements by Body CAP capsule at all time points will function as backup.
- Composite score, resulting in shivering present (Yes/No)
- Respiratory rate, end-tidal pCO2, SpO2, blood pressure, heartrate, ECG, RASS, difference between temperature at termination and lowest temperature measured after extrication from cold exposure, thermal discomfort VAS(0-10), pain VAS (0-10), nausea yes/no (if yes: mild, moderate or severe), concentration of normeperidine at presumed maximum outside reference range, capillary blood glucose outside reference range measured 30 min after extrication from cold exposure, skin temperature <8C.
研究者
Ane Helland
Scientific
Helse Bergen HF