Status:
COMPLETED
Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium
Lead Sponsor:
Peking University First Hospital
Conditions:
Older Patients
Nasal Administration
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Emergence delirium is common in older patients after surgery and associated with worse perioperative outcomes, including increased postoperative delirium. Nasal administrations of both dexmedetomidine...
Detailed Description
Delirium is a common brain dysfunction syndrome in older patients after major surgery. Delirium that occurs after surgery includes emergence delirium and postoperative delirium. Emergence delirium occ...
Eligibility Criteria
Inclusion
- Aged ≥ 65 years;
- Scheduled for inpatient elective or semi-elective surgery under general anesthesia, with an expected surgical duration of ≤2 hours;
- Planned to stay in hospital for at least 1 day after surgery.
Exclusion
- Not suitable for intranasal drug administration due to nasal disease (e.g., rhinitis, nasal polyps, or nasal congestion due to any cause);
- Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium;
- Inability to communicate due to coma, severe dementia, or language barrier before surgery;
- Brain trauma or neurosurgery;
- Use of sedatives or hypnotics at bedtime during the last month;
- History of hyperthyroidism or pheochromocytoma;
- 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;
- Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (receiving dialysis before surgery), or American Society of Anesthesiologists classification ≥ IV;
- Planned admission to the intensive care unit after surgery;
- Allergic to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06566469
Start Date
September 2 2024
End Date
May 1 2025
Last Update
July 31 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034