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

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

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

Esketamine combined with dexmedetomidine
Dexmedetomidine

Treatment groups

388 Participants

are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov