EUCTR2005-002926-67-DE进行中（未招募）不适用
An open-label, randomized, phase IIIB, multicenter trial to evaluate the pharmacodynamic parameters of intubation bolus, and bolus and infusion maintenance doses of Zemuron® in pediatric and adolescent subjects
V Organon0 个研究点目标入组 120 人开始时间: 2005年11月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Males or non-pregnant (determined by urine or serum HCG test), non-nursing females from birth to =<17 years of age; and
- •Subjects of ASA Class 1, 2, or 3 scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects > 17 years of age or preterm neonates (< 37 weeks gestational age at birth);
- •Subjects with congenital anomalies or airway obstructions that would preclude visualization or intubation of the trachea;
- •Subjects with known significant renal or hepatic disorders determined by medical history, physical examination, or laboratory tests;
- •Subjects known or suspected of having neuromuscular disorders;
- •Subjects known or suspected of having personal or family history of malignant hyperthermia;
- •Subjects known or suspected of having allergy to narcotic analgesics, hypnotics, neuromuscular blocking agents, or other medications used during general anesthesia;
- •Subjects who are receiving medications (systemic corticosteroids, anticonvulsants, aminoglycosides, macrolides or polypeptide antibiotic) during the pre-trial period or who will be receiving medications (systemic corticosteroids, anticonvulsants, aminoglycosides, macrolides or polypeptide antibiotic) during the in-trial period in a dose regimen known to modify the action of neuromuscular blocking agents;
- •Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
- •Subjects participating as research subjects in another clinical trial not pre-approved by Organon within 30 days before this trial;
- •Subjects who have already participated in this trial; or
- •Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, the subject has not given appropriate assent to participate in accordance with the ethical principles that have their origin in the Declaration of Helsinki, the ICH Guideline for Good Clinical Practice, and applicable regulatory requirements.
研究者
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