EUCTR2016-004833-25-ES进行中（未招募）1 期
Synchronous effect of anesthetics on fMRI, EEG and clinical responses. Development of a more precise system for monitoring anesthetic effect.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1- Healthy adult volunteers of both sexes between the ages of 18 and 40 at the time of the visit.
- •2- Physical state ASA 1
- •Patients who sign informed consent indicating that they have been informed of all relevant aspects of the trial.
- •4- Analysis of drugs in negative urine at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1- Cranial cutaneous or anatomical alterations.
- •2- Allergy to propofol, remifentanil or any of its excipients.
- •3 - Body mass index (BMI) <18 or> 30 kg / m2.
- •4- Women who test positive at the screening visit, or who are breastfeeding. Women of childbearing age (considered to be fertile after menarche and to become post-menopausal permanently unless it is sterile). They should use contraception (considered highly effective, with a failure rate of less than 1%): combined estrogen and progestogen oral contraceptives, transdermal or intravaginal. Progestin hormone contraception alone or associated with inhibition of ovulation by oral, injectable or implantable route. Intrauterine device (IUD). Intrauterine system hormone releaser (IUS). Bilateral tubal occlusion, vasectomized partner, or sexual abstinence and negative test in serum or urine to be performed on the day of selection and MRI.
- •5- Criteria of airway or difficult ventilation, according to the criteria of the Catalan Society of Anesthesiology, Resuscitation and Therapeutics of Pain
- •6- Absence of accompanying adult at the end of the study.
- •7- Presence of cardiac pacemakers, other electronic devices or strange ferromagnetic targets in vulnerable locations of the organism, which contraindicate the performance of MRI.
- •8- Background or present presence of claustrophobia. Or subjects who can not stand still for more than 25 minutes.
- •9- Participation in some clinical research within 3 months prior to administration of the drug.
研究者
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