Status:
RECRUITING
Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients
Lead Sponsor:
Peking University First Hospital
Conditions:
Older Patients
Postoperative Care
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Patients in the intensive care unit (ICU) often develop anxiety and agitation, sleep disturbances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomid...
Detailed Description
An estimated 300 million surgical procedures are performed globally each year. Patients who have complex conditions and an elevated risk of postoperative complications frequently require admission to ...
Eligibility Criteria
Inclusion
- Aged 60 years or older;
- Admitted to the intensive care unit (ICU) after surgery;
- Expected to stay in the ICU for at least one night.
Exclusion
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
- Presence of preoperative delirium, or inability to communicate due to coma, severe dementia, or language barrier;
- Previously diagnosed obstructive sleep apnea, judged to be at high risk of moderate-to-severe obstructive sleep apnea according to the STOP-Bang questionnaire, or have a body mass index \>30 kg/m²;
- Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 bpm), second-degree or higher atrioventricular block without a pacemaker, or systolic blood pressure \<90 mmHg despite use of vasopressors;
- Comorbid with hyperthyroidism or pheochromocytoma;
- Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours;
- After traumatic brain injury or neurosurgery;
- Allergy to dexmedetomidine and/or esketamine;
- Other conditions that are considered unsuitable for study participation.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07151716
Start Date
October 21 2025
End Date
October 1 2026
Last Update
November 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034