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临床试验/NCT03103360
NCT03103360已完成不适用

Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia

Pr Isabelle CONSTANT1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Relationship between pre-incision pupillary pain index and post-incision heart rate increase

研究概览

简要总结

During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • patient requiring general anesthesia
  • surgical procedure involving a skin incision
  • no regional anesthesia
  • written informed consent

排除标准

  • neurologic or ophthalmic disease

结局指标

主要结局

Relationship between pre-incision pupillary pain index and post-incision heart rate increase

时间窗: 4 minutes: one minute before incision, 3 minutes after incision

Relationship between pre-incision pupillary pain index and post-incision bispectral index increase

时间窗: 4 minutes: one minute before incision, 3 minutes after incision

Relationship between pre-incision pupillary pain index and post-incision movement occurrence

时间窗: 4 minutes: one minute before incision, 3 minutes after incision

Relationship between pre-incision pupillary pain index and post-incision blood pressure increase

时间窗: 4 minutes: one minute before incision, 3 minutes after incision

次要结局

未报告次要终点

研究者

发起方
Pr Isabelle CONSTANT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pr Isabelle CONSTANT

Professor

Hôpital Armand Trousseau

研究点 (1)

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