Clinical Trial

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

Study acronym: ESSENTIAL
Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-06-11
critical Primary endpoint(s) modified 2026-05-30
notable Enrollment increased: 132 -> 388 participants 2026-05-30
notable Enrollment increased: 86 -> 132 participants 2026-04-14
Trial Details
NCT Number NCT07377981
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Dexmedetomidine, Ketamine, Analgesia, Respiratory Therapy, Intensive Care Units (ICUs), Agitation, Sedation and Analgesia
Enrollment 388 participants
Start Date 2026-08-01
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10