- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hongjiao Xu, PhD
- Telefonnummer: 18917909818
- E-mail: gillianxu1987@163.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
fBFI - ENO score
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The occurrence of emergence delirium during the recovery period of general anesthesia
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
delirium stratification
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20260602071746502
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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