drugset / Trial / NCT07377981
Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
Phase 4
Not yet recruiting
388 enrolled
The First Affiliated Hospital with Nanjing Medical University
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2029-01-01
- Completion
- 2029-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | — |
| Comparator | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | — |
| Subject | Esketamine | Other / unclassified | 0.125 mg/kg | — |
| Subject | Esketamine | Other / unclassified | 0.2 mg/kg | — |
Indications
No indication recorded.