The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A (Dexmedetomidine Group)

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

Group Type ACTIVE_COMPARATOR

Group A (Dexmedetomidine Group)

Intervention Type DRUG

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

Group B (Control Group)

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

Group Type PLACEBO_COMPARATOR

Group B (Control Group)

Intervention Type DRUG

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

Interventions

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Group A (Dexmedetomidine Group)

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

Intervention Type DRUG

Group B (Control Group)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No