Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients
Key facts
- Who runs it
- Peking University First Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 100 people enrolled
- Started
- 21 Oct 2025
- Ended
- 24 Apr 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dexmedetomidine
- Dexmedetomidine-esketamine combination
- Record updated
- 30 June 2026
Who can take part
- Age
- 60 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Allergy to dexmedetomidine and/or esketamine
- Other conditions that are considered unsuitable for study participation
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- DexmedetomidineExisting treatment, for comparison
Sedation is provided with dexmedetomidine (4 μg/ml dexmedetomidine) for up to 7 days or until discharge from the ICU.
- Dexmedetomidine-esketamine combinationTreatment being tested
Sedation is provided with dexmedetomidine-esketamine combination (2 μg/ml dexmedetomidine and 1 mg/ml esketamine) combination for up to 7 days or until discharge from the ICU.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Sedation With Dexmedetomidine-esketamine Combination on Delirium in Postoperative ICU Patients: a Randomized Controlled Pilot Trial
- Record updated
- 30 June 2026