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Not yet recruitingNCT07775768Updated Aug 20, 2026

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

An observational study in Emergence Delirium, Anesthesia, sponsored by Hongjiao Xu. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Hongjiao Xu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
880
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Emergence Delirium, Anesthesia

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Keywords

  • Emergence Delirium
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In context

Emergence Delirium

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's planned enrollment of 880 is above the median of 164 across 278 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

This is the only study on the registry with Hongjiao Xu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • General anesthesia with tracheal intubation is planned for elective non-cardiac surgery.
  • Age ≥18 years old, gender not limited;
  • (ASA) classification I-III;
  • Voluntarily participate in this project and sign the form.

Exclusion criteria

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 ( 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
880 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • fBFI - ENO score
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What researchers measure

Primary outcomes

  1. The occurrence of emergence delirium during the recovery period of general anesthesia

    Sedation-agitation scale,A score of 5 to 7 is judged as delirium

    Time frame: Within 1 hour after the operation

Secondary outcomes

  1. delirium stratification

    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.

    Time frame: within 1 hour after operation

  2. Postoperative NRS pain and medication

    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.

    Time frame: within 1 hour after operation

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.

Of 180 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 24 months is above that.

Counting every sponsor, half of 180 studies reached it within 21 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 20, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Aug 20, 2028
CompletionEst.
Aug 20, 2028
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07775768
Lead sponsor
Hongjiao Xu
Collaborators
Shanghai Pudong Hospital, Huashan Hospital, Jiangsu Taizhou People's Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Jiangqiao Hospital,Jiading District,Shanghai
Responsible party
Hongjiao Xu (Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Aug 20, 2028 (estimated)
Completion
Aug 20, 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Hongjiao Xu, PhD
Contact
gillianxu1987@163.com
18917909818

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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