Dexmedetomidine to reduce agitation during ventilator weaning

The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation in Critically Ill Patients"

This trial will try dexmedetomidine to see if it reduces agitation in adult ICU patients who are ready to be weaned from mechanical ventilation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Sohag University (other)
• Locations: 1 site (Sohag)
• Trial ID: NCT07066605 on ClinicalTrials.gov

What this trial studies

Critically ill adults on mechanical ventilation who are clinically ready for weaning and show agitation during a spontaneous breathing trial will be assigned to either a dexmedetomidine group or a control group. The study focuses on measuring the level of agitation (RASS) during the weaning process and compares outcomes between the two groups. Key eligibility includes age ≥18, mechanical ventilation ≥24 hours, and RASS ≥ +1 during the trial, while patients with dexmedetomidine hypersensitivity, hemodynamic instability, major neurologic impairment, or pregnancy/lactation are excluded. Outcomes will inform whether using dexmedetomidine during weaning improves patient comfort and the weaning experience.

Who should consider this trial

Good fit: Adults (18+) in the ICU who have been mechanically ventilated for at least 24 hours, are clinically ready for weaning, and demonstrate agitation (RASS ≥ +1) during a spontaneous breathing trial are ideal candidates.

Not a fit: Patients who are not agitated during weaning, those with unstable heart rate or blood pressure, significant neurologic impairment, known dexmedetomidine allergy, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, using dexmedetomidine could reduce agitation during ventilator weaning, potentially smoothing extubation and reducing complications and ICU time.

How similar studies have performed: Previous clinical work has shown dexmedetomidine can reduce agitation and aid comfort during mechanical ventilation in some ICU populations, though results vary by protocol and patient mix.

Eligibility criteria

Inclusion Criteria:

* Adult ICU patients (≥18 years).
* On mechanical ventilation ≥24 hours.
* Clinically ready for weaning.
* Agitation score RASS ≥ +1 during spontaneous breathing trial.
* Intubation for at least 4 days: 2 weeks.

Exclusion Criteria:

* Known hypersensitivity to dexmedetomidine.
* Hemodynamic instability (HR \< 50 bpm or MAP \< 60 mmHg).
* Neurological impairment affecting level of consciousness.
* Pregnancy or lactation.

Where this trial is running

Sohag

• Sohag University Hospital — Sohag, Egypt (RECRUITING)

Study contacts

• Study coordinator: Dalia A Hussein, Resident

Conditions: Dexmedetomidine