Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherap… (NCT07377981) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (ESSENTIAL Trial): Study Protocol of a Randomized Controlled Trial
China388 participantsStarted 2026-08-01
Plain-language summary
This investigator-initiated, randomized, controlled, single-blind, 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 a clinically prioritized hierarchical composite endpoint within 28 days, including intubation or tracheostomy, delirium duration, and agitation duration.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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 ≤80 years at the time of randomization;
. Hospitalized in the ICU (with an expected ICU stay \>24 hours);
. Patients with hyperactive delirium: meeting criteria for Confusion Assessment Method for the ICU (CAM-ICU)\[19\] 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 agitation which is diagnosed if the Richmond Agitation-Sedation Scale (RASS) score\[20\] is superior or equal to +1. (The RASS and CAM-ICU are used to assess sedation and delirium levels. Hyperactive delirium is defined as CAM-ICU positive with RASS \> +1);
. Receiving non-invasive respiratory support (eg. high-flow nasal cannula, CPAP, or non-invasive ventilation) at least for \>24 hours.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing esketamine combined with dexmedetomidine for hyperactive delirium in ICU patients who aren't on a ventilator — is that situation a close match to what I or my loved one is actually experiencing right now?
2Since this is a Phase 4 trial, does that mean both of these drugs are already approved and used in practice, and what does that tell us about how much is already known about their safety compared to earlier-phase studies?
3The trial is listed as 'not yet recruiting' — how long might it be before it opens, and are there currently available treatments for hyperactive ICU delirium that we should be considering in the meantime rather than waiting?
4The primary goal of this trial is to see whether this drug combination can reduce how long delirium and agitation last, and whether it can help avoid the need for intubation — given my specific condition, how realistic is it that those outcomes would matter for my care plan?
5What are the known risks of combining esketamine and dexmedetomidine, particularly things like changes in heart rate, blood pressure, or breathing, and how would those risks be monitored if I were in the ICU under this protocol?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A hierarchical composite endpoint within 14 days, including intubation or tracheostomy, delirium duration, and agitation duration
Timeframe: Usually within 14 days
Trial details
NCT IDNCT07377981
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Known or suspected allergy or Contraindications to any of the study drugs;
. Severe arrhythmias (e.g., ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, ventricular tachycardia, QTc interval ≥470 ms, severe bradycardia (heart rate \<40 beats per minute), etc.), or left ventricular ejection fraction (LVEF) \<30%;
. Recent administration of esketamine, dexmedetomidine or haloperidol within previous 72 hours.
. Pregnancy or lactation;
. Conditions that may affect efficacy assessment or cognitive function testing, such as blindness, deafness, aphasic, or coma patients;
. History of epilepsy or seizures;
. Patients with an estimated survival period of less than 48 hours as judged by the investigator;
. 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;