NCT07775768Not yet recruitingNot Applicable
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 sites880 target enrollmentStarted: August 20, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 880
- Primary Endpoint
- The occurrence of emergence delirium during the recovery period of general anesthesia
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The occurrence of emergence delirium during the recovery period of general anesthesia
Time Frame: Within 1 hour after the operation
Sedation-agitation scale，A score of 5 to 7 is judged as delirium
Secondary Outcomes
- delirium stratification(within 1 hour after operation)
- Postoperative NRS pain and medication(within 1 hour after operation)
Investigators
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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