NCT07775768尚未招募不适用
Verification and Stratified Study on the Predictive Efficacy of fBFI - ENO Score for Awakening Restlessness in Patients Under General Anesthesia: A Prospective, Multicenter, Observational Cohort Study.
Hongjiao Xu0 个研究点目标入组 880 人开始时间: 2026年8月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 880
- 主要终点
- The occurrence of emergence delirium during the recovery period of general anesthesia
研究概览
简要总结
The aim of this study is to verify the generalizability of the fBFI-ENO score (extraversion + neuroticism - openness) constructed based on the Rapid Big Five Personality Scale - 10 across different genders, ages, and surgical types,which has shown good predictive ability for Emergence Delirium in previous studies.
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
- All
- 接受健康志愿者
- 否
入选标准
- •General anesthesia with tracheal intubation is planned for elective non-cardiac surgery.
- •Age ≥18 years old, gender not limited;
- •American Society of Anesthesiologists (ASA) classification I-III;
- •Voluntarily participate in this project and sign the informed consent form.
排除标准
- •The anesthesia method was temporarily changed to local anesthesia, regional anesthesia or intravenous anesthesia;
- •There was a clear cognitive dysfunction before the surgery (MMSE score lower than the qualified standard corresponding to the educational level: illiterates ≤ 17 points; primary school level ≤ 20 points; secondary (technical secondary) school level: ≤ 22 points; university (college) and above level: ≤ 23 points) or communication difficulties;
- •There is a history of mental illness or long-term use of psychotropic drugs;
- •It is expected to be transferred to the intensive care unit (ICU) immediately after the surgery or requires a sedated state and cannot undergo standard assessment in the PACU;
- •Has participated in or is currently participating in other clinical trials within 1 month;
- •The investigator determines that there are other circumstances that are not suitable for participating in this trial.
结局指标
主要结局
The occurrence of emergence delirium during the recovery period of general anesthesia
时间窗: Within 1 hour after the operation
Sedation-agitation scale，A score of 5 to 7 is judged as delirium
次要结局
- delirium stratification(within 1 hour after operation)
- Postoperative NRS pain and medication(within 1 hour after operation)
研究者
Hongjiao Xu
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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