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NCT Number: NCT07775768

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongjiao Xu, PhD

CONTACT

[email protected]

18917909818

Sponsors and collaborators

Lead sponsor

Hongjiao Xu

Other

Collaborators

  • Huashan Hospital
  • Jiangqiao Hospital,Jiading District,Shanghai
  • Jiangsu Taizhou People's Hospital
  • Shanghai Pudong Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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