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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

NCT07377981 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Esketamine combined with dexmedetomidine

Patients will receive a loading dose of esketamine at 0.1 mg/kg (subanesthetic dose) without a concomitant loading dose of dexmedetomidine. This will be followed by a continuous intravenous infusion (pump driven) of esketamine at 0.125-0.20 mg/(kg·h) (subanesthetic dose) combined with dexmedetomidine at 0.2-0.5 μg/kg/h. The infusion will be maintained until the patient fulfills the criteria of both a negative CAM ICU assessment and a RASS score between -2 and +1.

DRUG

Dexmedetomidine

Patients will receive a loading dose of normal saline (0.1 mL/kg), without a loading dose of dexmedetomidine. This will be followed by a continuous intravenous infusion (pump driven) of normal saline at an equivalent volume to the esketamine infusion rate (simulating 0.125-0.20 mg/(kg·h)), combined with dexmedetomidine at 0.2-0.5 μg/kg/h. The infusion will be continued until the patient meets both criteria: a negative CAM ICU assessment and a RASS score between -2 and +1.

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
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

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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