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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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07775768
Enrollment
880
Registered
2026-08-20
Start date
2026-08-20
Completion date
2028-08-20
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Anesthesia

Keywords

Emergence Delirium

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.

Interventions

None listed

Sponsors

Hongjiao Xu
Lead SponsorOTHER
Shanghai Pudong Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
Jiangsu Taizhou People's Hospital
CollaboratorOTHER
Shanghai Pulmonary Hospital, Shanghai, China
CollaboratorOTHER
Jiangqiao Hospital,Jiading District,Shanghai
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The occurrence of emergence delirium during the recovery period of general anesthesiaWithin 1 hour after the operationSedation-agitation scale,A score of 5 to 7 is judged as delirium

Secondary

MeasureTime frameDescription
delirium stratificationwithin 1 hour after operationLight: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.
Postoperative NRS pain and medicationwithin 1 hour after operationNRS (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.

Contacts

CONTACTHongjiao Xu, PhD
gillianxu1987@163.com18917909818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026