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NOT YET RECRUITING

NCT07377981

PHASE4

An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyperactive Delirium

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This investigator-initiated, randomized, controlled, superiority trial aims to assess the efficacy and safety of esketamine combined with dexmedetomidine for the management of agitation or delirium in intensive care unit (ICU) patients receiving non-invasive respiratory support. The primary endpoint is the duration of delirium.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-22

Completion Date

2029-01-01

Last Updated

2026-03-02

Healthy Volunteers

Conditions

Dexmedetomidine Ketamine Analgesia Respiratory Therapy Intensive Care Units (ICUs)Agitation Sedation and Analgesia

Interventions

DRUG

Esketamine combined with dexmedetomidine

Patients will receive a loading dose of esketamine at 0.1 mg/kg (subanesthetic dose) without a concomitant loading dose of dexmedetomidine. This will be followed by a continuous intravenous infusion (pump driven) of esketamine at 0.125-0.20 mg/(kg·h) (subanesthetic dose) combined with dexmedetomidine at 0.2-0.5 μg/kg/h. The infusion will be maintained until the patient fulfills the criteria of both a negative CAM ICU assessment and a RASS score between -2 and +1.

DRUG

Dexmedetomidine

Patients will receive a loading dose of normal saline (0.1 mL/kg), without a loading dose of dexmedetomidine. This will be followed by a continuous intravenous infusion (pump driven) of normal saline at an equivalent volume to the esketamine infusion rate (simulating 0.125-0.20 mg/(kg·h)), combined with dexmedetomidine at 0.2-0.5 μg/kg/h. The infusion will be continued until the patient meets both criteria: a negative CAM ICU assessment and a RASS score between -2 and +1.

Inclusion Criteria: 1. Age ≥18 years and ≤90 years; 2. Hospitalized in the Intensive Care Unit (ICU) or receiving ICU-level care (with an expected ICU stay \>24 hours); 3. Patients with hyperactive delirium: meeting criteria for CAM-ICU positivity (i.e., acute onset or fluctuating course plus inattention, and at least one secondary criterion-disorganized thinking or altered level of consciousness) and having a Richmond Agitation-Sedation Scale (RASS) score \> +1. (The RASS and the Confusion Assessment Method for the ICU (CAM-ICU) are used to assess sedation and delirium levels. Hyperactive delirium is defined as CAM-ICU positive with RASS \> +1); 4. Receiving non-intubated respiratory support (for \>12 hours); 5. Body Mass Index (BMI) between 18 kg/m² and 30 kg/m² for each patient. Exclusion Criteria: 1. Known or suspected allergy to any of the study drugs; 2. Acute myocardial infarction, severe arrhythmias (e.g., ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, ventricular tachycardia, QTc interval ≥470 ms, etc.), or left ventricular ejection fraction (LVEF) \<30%; 3. Severe bradycardia (heart rate \<40 beats per minute) with significant symptoms and hemodynamic instability; 4. Pregnancy or lactation; 5. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness or deafness; 6. History of epilepsy or seizures; 7. Severe central nervous system disorders (e.g., cerebrovascular accident, coma, etc.); 8. Neuropsychiatric conditions per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that may introduce bias (e.g., active substance use disorder, psychosis, etc.), including alcoholism, drug abuse, or use of psychotropic medications; 9. Patients receiving non-intubated respiratory support via a tracheostomy; 10. Patients with untreated or inadequately treated hyperthyroidism; 11. Patients with poorly controlled hypertension (resting systolic/diastolic blood pressure \>180/100 mmHg); 12. Patients or their legally authorized representatives (family members) who are unable to cooperate or unwilling to provide written informed consent; 13. Severe hepatic insufficiency (Child-Pugh grade C); 14. Severe renal dysfunction, defined as: chronic renal insufficiency with a glomerular filtration rate (GFR) ≤ 29 mL/min/1.73 m²; or subjects on long-term maintenance hemodialysis or peritoneal dialysis; 15. A history of sleep disorders requiring medical intervention within the past month; 16. Other conditions deemed unsuitable for inclusion by the investigators.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China