Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years;
Receiving invasive or non-invasive mechanical ventilation in the ICU, with an expected duration ≥24 hours;
Require sedation as judged by ICU physicians.
Disqualifiers
Pregnant or lactating women;
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
Unable to communicate due to coma, severe dementia, or language barrier prior to invasive/non-invasive mechanical ventilation;
After stroke, hypoxic encephalopathy, traumatic brain injury, or neurosurgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine-Esketamine Combination
DrugFor 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
DrugFor 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.
Treatment groups
1,508 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine-Esketamine CombinationExperimental treatment 1 intervention
Group B: DexmedetomidineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of delirium within 7 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 7-day period after enrollment or until hospital discharge. Positive result of delirium assessments at any timepoint is defined as occurrence of delirium.
Time frame
Up to 7 days after enrollmentSecondary outcomes
1
Days alive without delirium or come during the 7-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.
Time frame
Up to 7 days after enrollment2
Ventilator-free days within 30 days
Mechanical ventilation includes both invasive and non-invasive ventilation, but do not include high-flow nasal oxygenation.
Time frame
Up to 30 days after enrollment3
Length of stay in the ICU
Length of stay in the ICU.
Time frame
Up to 30 days after enrollment4
30-day all-cause mortality
30-day all-cause mortality.
Time frame
Up to 30 days after enrollmentOther outcomes
1
Proportion of patients without delirium
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 7-day period after enrollment or until hospital discharge.
Time frame
Up to 7 days after enrollment2
Proportion of patients without delirium or coma
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.
Time frame
Up to 7 days after enrollment3
Length of stay in hospital after enrollment
Length of stay in hospital after enrollment.
Time frame
Up to 30 days after enrollment4
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.
Time frame
Up to 30 days after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University International Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
Source ClinicalTrials.gov
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