Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability

• Status: Suspended
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy, occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported incidence may be partially attributed to inconsistent definitions and study populations. The significance of this hemodynamic instability is not only highlighted by its high incidence but also the need for corrective interventions. In one study, hemodynamic instability requiring clinical intervention occurred in nearly one third of ICU patients receiving dexmedetomidine. Moreover, patients who experienced dexmedetomidine-associated hypotension had a higher mortality rate than those who did not.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Adult patients (18-65 years old)

• admitted to Intensive care units in Assiut university Hospital

• requiring endotracheal intubation, mechanical ventilation and light to moderate sedation

• of an estimated duration not less than 24h.

Exclusion Criteria:

• History of coronary care unit admission.

• Severe traumatic brain injury.

• Low baseline arterial blood pressure defined as SBP <100 mm Hg or mean arterial blood pressure (MAP) <70 mm Hg in the 60 minutes preceding dexmedetomidine initiation.

• Slow baseline heart rate was <70 bpm in the 60 minutes preceding dexmedetomidine initiation.

• Spinal cord injury.

• Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.

• Patients who are admitted with a primary diagnosis of substance withdrawal.

• Pregnant females.

• Patients who are incarcerated.