About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hongjiao Xu
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor institution
Shanghai Pudong Hospital
Collaborator
Huashan Hospital
Collaborator
Jiangsu Taizhou People's Hospital
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Jiangqiao Hospital,Jiading District,Shanghai
Collaborator
This trial is not recruiting at the moment. You can still explore other options: