Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients
NCT Number: NCT06468436
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aged|Intensive Care Units|Ventilators, Mechanical|Dexmedetomidine|Esketamine|Delirium
Interventions: DRUG: Dexmedetomidine-Esketamine Combination|DRUG: Dexmedetomidine
Sponsor: Peking University First Hospital
Collaborators: Peking University International Hospital|Tianjin Medical University General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1508
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2030-12
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China|Peking University International Hospital, Beijing, Beijing, 102206, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China

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.

Primary Outcome Measures: Incidence of delirium within 14 days, Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) during the 14-day period after enrollment or until hospital discharge. Positive result of delirium assessments at any timepoint is defined as occurrence of delirium., Up to 14 days after enrollment
Secondary Outcome Measures: Days alive without delirium or come during the 14-day period, Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM). Coma is defined as Richmond Agitation Sedation Scale (score ranges from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calms) of -4 or -5. Positive results at any timepoint is defined as occurrence of delirium or coma., Up to 14 days after enrollment|Ventilator-free days within 30 days, Mechanical ventilation includes both invasive and non-invasive ventilation, but do not include high-flow nasal oxygenation., Up to 30 days after enrollment|Length of stay in the ICU, Length of stay in the ICU., Up to 30 days after enrollment|30-day all-cause mortality, 30-day all-cause mortality., Up to 30 days after enrollment
Other Outcome Measures: Proportion of patients without delirium within 14 days, Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM) during the 14-day period after enrollment or until hospital discharge., Up to 14 days after enrollment|Proportion of patients without delirium or coma within 14 days, Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-Minute Diagnostic Assessment for Delirium using the Confusion Assessment Method (3D-CAM). Coma is defined as Richmond Agitation Sedation Scale (score ranges from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calms) of -4 or -5., Up to 14 days after enrollment|Length of stay in hospital after enrollment, Length of stay in hospital after enrollment., Up to 30 days after enrollment|Incidence of major complications within 30 days, Major complications are defined as new-onset medical conditions other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification., Up to 30 days after enrollment|Cognitive function at 30 days, Cognitive function is assessed with the Montreal Cognitive Assessment-telephone version (T-MoCA; score ranges from 0 to 22, with higher score indicating better cognitive function)., At 30 days after enrollment|Quality of life at 30 days, Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function., At 30 days after enrollment