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临床试验/NCT01464489
NCT01464489已完成不适用

Study of Intubation Time Required for Excellent Tracheal Intubation With Low Dose Rocuronium During Propofol Anaesthesia in Children With and Without Atropine

Gachon University Gil Medical Center1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
intubation time

研究概览

简要总结

The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation.

详细描述

The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation. Therefore, the purpose of this study was to determine TimeEI with a low dose of esmeron (rocuronium) (0.3 mg.kg-1) for achievement of successful tracheal intubation conditions during intravenous (i.v.) anaesthesia using propofol and alfentanil in children and to determine whether administration of i.v. atropine (atropine sulphate) (10 μg.kg-1) during anaesthesia induction reduced these times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I,
  • Tonsillectomy with adenoidectomy

排除标准

  • Patients with known allergy to the drugs used in this study,
  • A history of reactive airway disease and asthma,
  • A neuromuscular disorder, an anticipated difficult airway, and
  • Crying children on arrival in the operating theatre

研究组 & 干预措施

Control group

Experimental

Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1.And receive normal saline for control group

干预措施: Atropine (Drug)

Atropine group

Active Comparator

Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1. And receive atropine (atropine sulfate) 10 μg.kg-1 for atropine group.

干预措施: Normal saline (Drug)

结局指标

主要结局

intubation time

时间窗: intubating condition at 120 seconds from rocuronium injection

Tracheal intubation was attempted was predetermined according to the up-and-down method, starting with 120 s, in both groups. If intubation was successful (unsuccessful), the assigned intubation time was decreased (increased) by one interval for the next patients in that group, respectively. In this study, the investigators adopted 69, 83, 99, 120, 144, 173, and 208 s, since these intubation times have equal intervals (0.08) on a logarithmic scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youn Yi Jo

assistant professor

Gachon University Gil Medical Center

研究点 (1)

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