Emergence Delirium, AnesthesiaNCT07775768
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 of Emergence Delirium, Anesthesia, run by Hongjiao Xu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence Delirium, Anesthesia
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Aug 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Emergence Delirium, Anesthesia
- Keywords
- Emergence Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| fBFI - ENO score | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 hour after the operation
Secondary outcomes (2)
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.
Measured: within 1 hour after operation
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.
Measured: within 1 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Aug 2028 (estimated)
- Study completion20 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium, AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 880 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hongjiao Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Hospital, Huashan Hospital, Jiangsu Taizhou People's Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Jiangqiao Hospital,Jiading District,Shanghai
- Responsible party
- Sponsor-investigator, Hongjiao Xu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775768
- Sponsor's protocol ID
- 20260602071746502
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07775768
- Acronym / sponsor ID
- 20260602071746502
- Conditions
- Emergence Delirium, Anesthesia
- Keywords
- Emergence Delirium
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Hongjiao XuUniversity, hospital or other
- Collaborators
- Shanghai Pudong Hospital, Huashan Hospital, Jiangsu Taizhou People's Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Jiangqiao Hospital,Jiading District,Shanghai
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 Aug 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fBFI - ENO score | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
delirium stratification
Time frame: within 1 hour after operation
Postoperative NRS pain and medication
Time frame: within 1 hour after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium, Anesthesia, run by Hongjiao Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongjiao Xu, PhD (18917909818, gillianxu1987@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of emergence delirium during the recovery period of general anesthesia (time frame: Within 1 hour after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.