NCT07151716 Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients
| NCT ID | NCT07151716 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Older Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-10-21 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Dexmedetomidine and ketamine are recommended for sedation and analgesia in postoperative ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the neuropsychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in postoperative ICU patients may reduce delirium.
Eligibility Criteria
Inclusion Criteria: 1. Aged 60 years or older; 2. Admitted to the intensive care unit (ICU) after surgery; 3. Expected to stay in the ICU for at least one night. Exclusion Criteria: 1. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; 2. Presence of preoperative delirium, or inability to communicate due to coma, severe dementia, or language barrier; 3. 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; 4. 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; 5. Comorbid with hyperthyroidism or pheochromocytoma; 6. Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours; 7. After traumatic brain injury or neurosurgery; 8. Allergy to dexmedetomidine and/or esketamine; 9. Other conditions that are considered unsuitable for study participation.
Contact & Investigator
Dong-Xin Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07151716 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Older Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07151716 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07151716 currently recruiting?
Yes, NCT07151716 is actively recruiting participants. Contact the research team at wangdongxin@hotmail.com for enrollment information.
Where is the NCT07151716 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07151716 clinical trial?
NCT07151716 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 100 participants.