Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05401058
Eligibility Criteria:
Inclusion Criteria:
* Age≥65 years
* American Society of Anesthesiologists (ASA): I-III
* Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery
* Estimated operation time more than 2 hours
* Not expected to be admitted to ICU postoperatively
* Proficient in Chinese
* Informed consent
Exclusion Criteria:
* Morbid obesity with BMI \>35 kg/m2;
* History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc;
* Corrected QT (QTc) of electrocardiogram\> 500ms;
* Preoperative liver insufficiency (Child Pugh grade C);
* End-stage renal disease requiring dialysis;
* Severe heart failure \[Metablic equivalent (METs)\<4\];
* Allergic to droperidol;
* Inability to communicate due to coma or dementia in preoperative period;
* Preoperative delirium, assessed by 3D-CAM;
* More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits);
* Participating in conflicting clinical trials;
* Expected to have an additional operation within 7 days after the index operation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05401058
Study Brief:
Protocol Section:
NCT05401058