跳至主要内容
临床试验/NCT00693875
NCT00693875已完成不适用

The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study

Capital Medical University25 个研究点 分布在 1 个国家目标入组 11,197 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,197
试验地点
25
主要终点
evaluation of intra-operative awareness in all the patients investigated

研究概览

简要总结

Medical literature about awareness during general anesthesia is rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5~6%) of intra-operative awareness compared with western countries. The investigators sponsored this multicenter, large sampled, prospective study to determine the incidence of intra-operative awareness in China, and the preservation effect of BIS monitor on the incidence of awareness.

详细描述

Background: The incidence of awareness in patients undergoing general anesthesia has been reported in as many as 0.1~0.2% in western countries. But so far,medical literature about awareness during general anesthesia is still rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5~6%) of intra-operative awareness. We believed that this multicenter, large sampled, prospective study would be very necessary for us to determine the incidence of intra-operative awareness in China, and analysis of the relevant factors would help us to understand why was the incidence of awareness in China much higher than that in western countries.

Methods: This is a prospective, nonrandomized descriptive cohort study that was conducted at 25 academic medical centers in China. 11,197 patients (age>12, intubation or LMA during anesthesia) form 25 medical centers were enrolled to be interviewed by research stuff for evaluation of awareness at the 1st and 4th day after their general anesthesia. The structured interview questions were:⑴What is the last thing you remembered before you went to sleep? ⑵What is the first thing you remembered when you woke up? ⑶Can you remember anything between these two periods? ⑷Did you dream during your operation? ⑸What was the worst thing about your operation? An evaluation committee independent from the research stuff was constituted to verify the data from the medical centers. And then the incidence of intra-operative awareness in China was determined. General condition and details of the anesthesia procedure of the patients were also recorded during the anesthesia for a binary logistic regression analysis.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients received general anesthesia with tracheal intubation or LMA
  • Apparently normal mental status

排除标准

  • Pediatric patients (<12 yr)
  • Those who could not be interviewed in 24 hours after the operations
  • Those unable to communicate in common spoken Chinese

结局指标

主要结局

evaluation of intra-operative awareness in all the patients investigated

时间窗: within 4 days after the general anesthesia

次要结局

未报告次要终点

研究者

发起方
Capital Medical University
申办方类型
Other

研究点 (25)

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