The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation

Sohag University

Status: Enrolling

Conditions: Dexmedetomidine

Treatments: Drug: Group A (Dexmedetomidine Group); Drug: Group B (Control Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT07066605

Soh-Med-25-6---17MS

Details and patient eligibility

About

This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients.

Enrollment: 62 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

Group A (Dexmedetomidine Group)

Active Comparator group

Description:

patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.

Treatment:

Drug: Group A (Dexmedetomidine Group)

Group B (Control Group)

Placebo Comparator group

Description:

patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)

Treatment:

Drug: Group B (Control Group)