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临床试验/NCT04697732
NCT04697732Unknown不适用

The Incidence of Intraoperative Awareness Under General Anesthesia in Adults: A Prospective, Multicenter Study

Baskent University Ankara Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2012年7月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30,000
试验地点
1
主要终点
Modified Brice interview

研究概览

简要总结

Intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. The aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with PTSD in Turkish adults.

Adult patients will be evaluated 4 time following emergence (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. Each interview will be conducted using the same structured interview (Brice Interview).

Descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. Logistic regression will be used to determine the risk factors associated with awareness and PTSD.

We believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,

排除标准

  • ASA V patients
  • Patients below 18 years of age,
  • Patient who can not give informed consent,
  • Patients who have known psychological or psychiatric problems,
  • Patients who are not suitable for postoperative follow-up

结局指标

主要结局

Modified Brice interview

时间窗: One month after emergence.

This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

次要结局

未报告次要终点

研究者

发起方
Baskent University Ankara Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahattin Tuncali

Associate professor, MD

Baskent University Ankara Hospital

研究点 (1)

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