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临床试验/NCT04808440
NCT04808440已完成不适用

Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Intubation condition

研究概览

简要总结

The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

详细描述

The recommended dose of a non-depolarizing curare to facilitate tracheal intubation is twice the active dose 95 (the dose that reduces muscle force by 95%). At this dosage, curarization of the laryngeal adductors allowing relaxation and abduction (opening) of the vocal cords is considered certain. With atracurium, the dose for intubation is 0.5 mg.kg-1 and the time to full effect is approximately 3 minutes. With the use of newer hypnotics, there are no data evaluating the conditions for intubation after a fixed time of 3 minutes as with current anesthetic practices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult female
  • Patient to undergo general anesthesia with intubation for scheduled gynecological surgery
  • Patient informed about the study and not opposed to it

排除标准

  • Patients with severe and morbid obesity (BMI>35kg/m2)
  • Pregnancy
  • Patients with difficult intubation
  • Allergy to atracurium and to any other drug used.
  • Patient under tutorship / curatorship
  • Not affiliated with social insurance
  • Patient with AME

结局指标

主要结局

Intubation condition

时间窗: 3 minutes after atracurium injection

The intubating conditions were evaluated on the basis of the consensus conference on Good Clinical Research Practice in Pharmacodynamic Studies of Neuromuscular Blocking Agents. The score used include the following variables: (1) ease of laryngoscopy, (2) vocal cord position, and (3) reaction to the insertion of the endotracheal tube and the cuff inflation (eg, diaphragmatic movement due to patient cough). Each of these variables was rated as (1) excellent, (2) good, or (3) poor. Intubating conditions were scored as excellent if all variables were excellent; the score was good if at least 1 variable was good and the rest were excellent; the conditions were considered poor if any of the variables was rated poor. Evaluation of intubation conditions with the use of atracurium after a fixed three-minute delay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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