MedTrace Logo

Efficacy and Safety of Esketamine Combined With Dexmedetomidine in Non-Invasive ICU Patients With Hyperactive Delirium (ESSENTIAL Trial): Protocol of a Randomized Controlled Trial

NCT07377981 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Esketamine combined with dexmedetomidine

Participants will receive esketamine at 0.125-0.20 mg/(kg·h) combined with dexmedetomidine at 0.2-0.5 μg/kg/h. Sedation will be targeted to maintain a RASS score between -1 and +1, prioritizing light sedation while ensuring adequate control of agitation. Drug titration will follow a protocolized, stepwise approach to minimize inter-physician variability: - If RASS ≥ +2, the esketamine infusion rate will be preferentially increased within the predefined range. - If agitation persists at the upper esketamine dose, dexmedetomidine may be increased within its allowed range. - If RASS between -1 and +1, the current dose will be maintained. - If RASS ≤ -2, esketamine will be reduced or temporarily discontinued first, followed by reduction of dexmedetomidine if necessary.

DRUG

Dexmedetomidine

Participants will receive dexmedetomidine at 0.2-0.5 μg/kg/h. Sedation will be targeted to maintain a Richmond Agitation-Sedation Scale (RASS) score between -1 and +1, prioritizing light sedation while ensuring adequate control of agitation. Drug titration will follow a protocolized, stepwise approach to minimize inter-physician variability: - If RASS ≥ +2, dexmedetomidine infusion will be increased within the predefined range. - If RASS ≤ -2, dexmedetomidine will be reduced or temporarily discontinued. Continuous infusion will be maintained for at least 36 hours after resolution of delirium, or until ICU discharge if earlier, to reduce the risk of relapse.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377981 on ClinicalTrials.gov