Optic

ID

Name

2024-239

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2030-06-01

Trial end

2030-12-01

Status

Not yet recruiting

Treatment

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.

Arms:

Dexmedetomidine-Esketamine Combination

Other names:

Dexmedetomidine hydrochloride, Esketamine hydrochloride

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.

Arms:

Dexmedetomidine

Other names:

Dexmedetomidine hydrochloride

Size

1508

Primary endpoint

Incidence of delirium within 14 days

Up to 14 days after enrollment

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1508, 'type': 'ESTIMATED'}}

Updated at

2024-06-21

Organization

Peking University First Hospital

Product

Dexmedetomidine-Esketamine Combination

Indication

Elderly

Indication

Intensive Care Unit

Indication

Ventilators