Not Yet RecruitingN/Aketamine

Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

Sponsored by Peking University First Hospital

NCT ID
NCT06468436
Target Enrollment
1,508 participants
Start Date
2025-11
Est. Completion
2030-12-01

About This Study

Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.

Conditions Studied

AgedIntensive Care UnitsVentilators, MechanicalDexmedetomidineEsketamineDelirium

Interventions

  • Dexmedetomidine-Esketamine Combination
  • Dexmedetomidine

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

1. Aged ≥18 years;
2. Receiving invasive or non-invasive mechanical ventilation in the ICU, with an expected duration ≥24 hours;
3. Require sedation as judged by ICU physicians.

Exclusion Criteria:

1. Pregnant or lactating women;
2. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
3. Unable to communicate due to coma, severe dementia, or language barrier prior to invasive/non-invasive mechanical ventilation;
4. After stroke, hypoxic encephalopathy, traumatic brain injury, or neurosurgery;
5. Comorbid with hyperthyroidism or pheochromocytoma;
6. 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;
7. Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours;
8. Allergy to dexmedetomidine and/or esketamine, or any other conditions that are considered unsuitable for study participation.

Study Locations (3)

Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Dong-Xin Wang, MD, PhD
CONTACT
8610 83572784wangdongxin@hotmail.com
Xian Su, MD, PhD
CONTACT
8610 83575138suxxxx@126.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

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