An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubate… (NCT07377981) | Clinical Trial Compass
Not Yet RecruitingPhase 4
An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyperactive Delirium: Protocol of a Randomized Controlled Trial
China132 participantsStarted 2026-06-02
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years and ≤90 years;
✓. Hospitalized in the Intensive Care Unit (ICU) or receiving ICU-level care (with an expected ICU stay \>24 hours);
✓. 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);
✓. Receiving non-intubated respiratory support (for \>12 hours);
✓. Body Mass Index (BMI) between 18 kg/m² and 30 kg/m² for each patient.
Exclusion criteria
✕. Known or suspected allergy to any of the study drugs;
✕. 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%;
✕. Severe bradycardia (heart rate \<40 beats per minute) with significant symptoms and hemodynamic instability;
✕. Pregnancy or lactation;
✕. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness or deafness;
What they're measuring
1
Duration of Delirium (Time with positive CAM-ICU)
Timeframe: Usually within 30 days
Trial details
NCT IDNCT07377981
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. Severe central nervous system disorders (e.g., cerebrovascular accident, coma, etc.);
✕. 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;