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临床试验/NCT02245789
NCT02245789已完成不适用

Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

Hopital Foch2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9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
发起方
Hopital Foch
入组人数
50
试验地点
2
主要终点
Required dose of opioid to counteract nociceptive stimulation

研究概览

简要总结

Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a conventional MacIntosh laryngoscope.

Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that it modifies the anesthetic drugs requirement. .

详细描述

All patients will received a standardized anesthetic procedure : combined closed-loop anesthesia system using bispectral index as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.

Patients will be randomized in two groups : intubation using a conventional MacIntosh laryngoscope or intubation using a videolaryngoscope.

If our hypothesis is confirmed, the required concentration of remifentanil, an opioid agent, will be reduced in the group using a videolaryngoscope.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient scheduled for a general anesthesia with orotracheal intubation

排除标准

  • predictable risk of difficult mask ventilation or of difficult tracheal intubation
  • necessity of a rapid sequence induction
  • contra-indication to the use of the automated administration of propofol and of remifentanil
  • contra-indication to the use of atracurium
  • Otolaryngology, thoracic surgery, or intracranial surgery

研究组 & 干预措施

Macintosh laryngoscope

Active Comparator

Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.

干预措施: Tracheal intubation (Procedure)

Macintosh laryngoscope

Active Comparator

Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.

干预措施: Propofol and remifentanil anesthesia (Drug)

McGrath Mac videolaryngoscope

Experimental

Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.

干预措施: Tracheal intubation (Procedure)

McGrath Mac videolaryngoscope

Experimental

Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.

干预措施: Propofol and remifentanil anesthesia (Drug)

结局指标

主要结局

Required dose of opioid to counteract nociceptive stimulation

时间窗: 1 hour

Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that the required maximal concentration of remifentanil is lower than when a standard laryngoscope is used.

次要结局

  • Complications of intubation(one day)
  • Characteristics of anesthesia(one hour)
  • Characteristics of tracheal intubation(one hour)
  • Ergonomic evaluation of the device(one hour)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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