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Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients
Sponsor: Peking University First Hospital
Summary
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.
Official title: Effect of Dexmedetomidine-Esketamine Combination for Sedation and Analgesia on Delirium in ICU Patients With Mechanical Ventilation: A Multicenter Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1508
Start Date
2025-11
Completion Date
2030-12-01
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
Dexmedetomidine-Esketamine Combination
For patients with invasive ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \[0.05×kg\] ml/h which is increased by \[0.025×kg\] ml/h every 10 min, until the Richmond Agitation-Sedation Scale (RASS) reaches -2 to -1, maximal infusion rate reaches \[0.175×kg\] ml/h, or adverse reactions occur. Daytime sedation (06:00-20:00) is provided as above when considered necessary by the ICU physicians, with a target RASS score of -2 to +1. For patients with non-invasive ventilation (including high-flow nasal oxygenation) or without assisted ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \[0.0125×kg\] ml/h which is increased by \[0.0125×kg\] ml/h every 10 min, until the RASS reaches -1, maximal infusion rate reaches \[0.05×kg\] ml/h, or adverse reactions occur. Daytime sedation (06:00-20:00) is typically not required but is provided when considered necessary by the ICU physicians, with a target RASS score of -1 to +1.
Dexmedetomidine
For patients with invasive ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \[0.05×kg\] ml/h which is increased by \[0.025×kg\] ml/h every 10 min, until the Richmond Agitation-Sedation Scale (RASS) reaches -2 to -1, maximal infusion rate reaches \[0.175×kg\] ml/h, or adverse reactions occur. Daytime sedation (06:00-20:00) is provided as above when considered necessary by the ICU physicians, with a target RASS score of -2 to +1. For patients with non-invasive ventilation (including high-flow nasal oxygenation) or without assisted ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \[0.0125×kg\] ml/h which is increased by \[0.0125×kg\] ml/h every 10 min, until the RASS reaches -1, maximal infusion rate reaches \[0.05×kg\] ml/h, or adverse reactions occur. Daytime sedation (06:00-20:00) is typically not required but is provided when considered necessary by the ICU physicians, with a target RASS score of -1 to +1.
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