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临床试验/NCT00620386
NCT00620386已完成2 期

Comparing Intubating Conditions and Hemodynamic Changes Between Macintosh Laryngoscopy and Bonfils Fibrescope During Endotracheal Intubation Without Neuromuscular Blockade

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
intubating conditions

研究概览

简要总结

We studied intubating conditions and hemodynamic changes during endotracheal intubation employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in 80 healthy patients candidates for elective surgery requiring endotracheal intubation. We omitted neuromuscular blocking drugs from the induction regimen.

详细描述

BACKGROUND:

Neuromuscular blocking drugs (NMBDs) are believed to be the dominating antigens causing bronchospasm and anaphylaxis during anaesthesia. Avoidance of these drugs, however, renders compromised intubating conditions and higher morbidity with conventional Macintosh laryngoscopy. Thus, we compared Macintosh laryngoscopy with Bonfils intubation fibrescope without administering NMBDs.

METHODS:

Eighty male and female patients scheduled for elective surgery, aged 15 to 60 years, ASA class II or I, non-obese, with lower risk for difficult intubation were enrolled in this study. They were randomly allocated into the Bonfils group or the Macintosh group (40 each). Following adequate hydration and preoxygenation, midazolam 0.05 mg kg-1 was administered, followed by alfentanil 20 µg kg-1, lidocaine 1.5 mg kg-1, and propofol 2 mg kg-1 intravenously. Tracheal intubation was then carried out using Bonfils intubation fibrescope (Bonfils group) or employing conventional Macintosh laryngoscopy (Macintosh group). The primary outcome measure was the intubating condition, with mean arterial blood pressure and heart rate as secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) physical status was class I or II
  • body mass index (BMI) < 30
  • ability to assume the 'sniffing' position

排除标准

  • drug users
  • expected to present difficult intubation
  • history of oesophageal reflux
  • any systemic or airway disease
  • known allergy to the protocol medications

结局指标

主要结局

intubating conditions

时间窗: 7 months

次要结局

  • mean arterial pressure (MAP)(7 months)
  • heart rate (HR)(7 months)
  • Pulse Oxygen Saturation (SpO2)(7 months)

研究者

申办方类型
Other

研究点 (1)

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