Emergence Delirium、fBFI-ENO Score (Extraversion + Neuroticism - Openness) Based on the Fast Big Five Personality Scale-10、An Adult Patient With ASAI-III Who is Scheduled for Elective Non-cardiac Surgery and is to Undergo General Anesthesia With Tracheal Intubation
August 16, 2026 updated by: Hongjiao Xu
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.
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
880
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongjiao Xu, PhD
- Phone Number: 18917909818
- Email: gillianxu1987@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for non-cardiac surgery, undergoing general anesthesia with endotracheal intubation, aged 18 years or older, and with ASA classification of I-III.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
fBFI - ENO score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Within 1 hour after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delirium stratification
Time Frame: within 1 hour after operation
|
Light：It occurs under strong stimulation, such as suctioning phlegm, but stops as soon as the stimulation disappears. Moderate:It occurs without stimulation and lasts for at least 5 minutes, but does not require medical staff intervention by the staff. Heavy:It should last for at least 5 minutes and must be controlled through medication and/or physical restraints. |
within 1 hour after operation
|
|
Postoperative NRS pain and medication
Time Frame: within 1 hour after operation
|
NRS (Numerical Rating Scale, Digital Evaluation Scale) is composed of 11 numbers from 0 to 10. Patients use these 11 numbers from 0 to 10 to describe the intensity of pain.
The higher the number, the more severe the pain.If NRS≥4，Sufentanil 5μg will be given.
|
within 1 hour after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 20, 2026
Primary Completion (Estimated)
August 20, 2028
Study Completion (Estimated)
August 20, 2028
Study Registration Dates
First Submitted
August 11, 2026
First Submitted That Met QC Criteria
August 16, 2026
First Posted (Actual)
August 20, 2026
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
August 16, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20260602071746502
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.