RecruitingPhase 4NCT07151716

Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

Effect of Sedation With Dexmedetomidine-esketamine Combination on Delirium in Postoperative ICU Patients: a Randomized Controlled Pilot Trial

Sponsor

Peking University First Hospital

Enrollment

100 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Older Patients Esketamine Dexmedetomidine Delirium Intensive Care Unit Postoperative Care

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

Min Age: 60 Years

Inclusion Criteria3

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 Criteria9

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.

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Interventions

DRUGDexmedetomidine

For patients with endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.2 μg/kg/h dexmedetomidine and increased/decreased by 0.1 μg/kg/h dexmedetomidine every 15 min, until the Richmond Agitation-Sedation Scale (RASS) reaches -2 to -1, maximal infusion rate reaches 0.7 μg/kg/h dexmedetomidine, or adverse reactions occur. Daytime (06:00-20:00) sedation is provided as above when considered necessary, with a target RASS score of -2 to +1. For patients without endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.10 μg/kg/h dexmedetomidine and increased/decreased by 0.05 μg/kg/h dexmedetomidine every 15 min, until the RASS reaches -1, maximal infusion rate reaches 0.2 μg/kg/h dexmedetomidine, or adverse reactions occur. Daytime (06:00-20:00) sedation is typically not provided.

DRUGDexmedetomidine-esketamine combination

For patients with endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.1 μg/kg/h dexmedetomidine and 0.05 mg/kg/h esketamine, increased/decreased by 0.05 μg/kg/h dexmedetomidine and 0.025 mg/kg/h esketamine every 15 min, until the RASS reaches -2 to -1, maximal infusion rate reaches 0.35 μg/kg/h dexmedetomidine and 0.175 mg/kg/h esketamine, or adverse reactions occur. Daytime (06:00-20:00) sedation is provided as above when considered necessary, with a target RASS score of -2 to +1. For patients without endotracheal intubation, nighttime (20:00-06:00) sedation is initiated with 0.05 μg/kg/h dexmedetomidine and 0.025 mg/kg/h esketamine, and increased/decreased by 0.025 μg/kg/h dexmedetomidine and 0.0125 mg/kg/h esketamine every 15 min, until the RASS reaches -1, maximal infusion rate reaches 0.1 μg/kg/h dexmedetomidine and 0.05 mg/kg/h esketamine, or adverse reactions occur. Daytime (06:00-20:00) sedation is typically not provided.