Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

NANot yet recruitingINTERVENTIONAL
Enrollment

1,508

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

December 1, 2029

Study Completion Date

December 1, 2030

Conditions
AgedIntensive Care UnitsVentilators, MechanicalDexmedetomidineEsketamineDelirium
Interventions
DRUG

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."

DRUG

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."

Trial Locations (3)

100034

Peking University First Hospital, Beijing

102206

Peking University International Hospital, Beijing

300052

Tianjin Medical University General Hospital, Tianjin

All Listed Sponsors
collaborator

Peking University International Hospital

OTHER

collaborator

Tianjin Medical University General Hospital

OTHER

lead

Peking University First Hospital

OTHER

NCT06468436 - Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients | Biotech Hunter | Biotech Hunter