EUCTR2020-005886-15-NL进行中（未招募）1 期
Evaluation of pharmacokinetic and –dynamic characteristics of norepinephrine for the augmentation of arterial blood pressure in healthy volunteers prior to and during general anesthesia - VASOCONTROL-I
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
- 36
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
- •-?American Society of Anesthesiologists (ASA) Physical Status I or II
- •-?No exclusion criterion is present
- •-?Informed, and willing to give written informed consent.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •-?Refusal of the volunteer to participate
- •-?Pregnancy
- •-?Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator)
- •-?A difference > 15 mmHg in measured systolic or diastolic blood pressure value (SBP, DBP) between the left and right upper arm, as determined by non-invasive cuff oscillometry during the screening visit.
- •-?An increased risk of difficult mask ventilation or tracheal intubation, as judged by the anesthesiologist-researcher.
- •-?Pulmonary disease
- •-?Gastric or endocrinologic diseases
- •-?End-stage liver or kidney failure
- •-?Use of tricyclic antidepressive medication or MAO inhibitors.
研究者
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