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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT06566469
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥ 65 years;
2. Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;
3. Planned to stay in hospital for at least 1 day after surgery.
Exclusion Criteria:
1. Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause);
2. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
3. Inability to communicate due to coma, severe dementia, or language barrier before surgery;
4. Brain trauma or neurosurgery;
5. Use of sedatives or hypnotics at bedtime during the last month;
6. History of hyperthyroidism or pheochromocytoma;
7. Preoperative left ventricular ejection fraction \<30%, or sick sinus node syndrome, severe sinus bradycardia (heart rate \<50 beats per minute), or atrioventricular block of degree II or higher without pacemaker, or systolic blood pressure \<90 mmHg before enrollment;
8. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;
9. Planned admission to the intensive care unit after surgery;
10. Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06566469
Study Brief:
Protocol Section:
NCT06566469