Intubation; Difficult Clinical Trial
Official title:
A Prospective, Randomized, Controlled Study on the Use of Dexmedetomidine to Facilitate Extubation in Surgical Intensive-Care-Unit Patients Who Failed Previous Weaning Attempts
Mechanical ventilation commonly is associated with patient agitation requiring sedation to
alleviate discomfort and reduce excessive central respiratory drive. Upon recovery from
acute respiratory failure, sedation is reduced to facilitate the withdrawal of ventilatory
support. In some patients, abrupt reduction in sedation provokes severe agitation that
causes catecholamine release resulting in severe hypertension, tachycardia and tachypnea.
This requires increased sedation to bring hemodynamic and respiratory function under
control.
Dexmedetomidine is an alpha-2 receptor agonist with both sedative and analgesic properties
that allows for the reduction in the anesthetic and analgesic requirements in the
perioperative setting. In addition to its sedative effects, alpha-2 receptor stimulation in
the central nervous system inhibits sympathetic activity and reduces plasma epinephrine and
norepinephrine levels, thereby lowering both arterial blood pressure and heart rate. Because
alpha-2 receptor stimulation does not cause respiratory depression, dexmedetomidine may
facilitate the transition to unassisted breathing in profoundly agitated patients. The
investigators will prospectively evaluate dexmedetomidine in 30 patients who could not be
extubated because of agitation with hemodynamic instability and tachypnea.
The purpose of this study is to test if a larger prospective randomized controlled pilot
study can show that dexmedetomidine facilitates weaning and extubation in patients who have
failed previous attempts because of agitation and hyperdynamic cardiopulmonary response.
Status | Terminated |
Enrollment | 42 |
Est. completion date | December 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: 1. Age less than 70 years old 2. Normothermia (36.5 degrees centigrade) 3. Normal sinus rhythm 4. Hemodynamically stable (systolic blood pressure [SBP] > 110 mmHg) 5. Ejection fraction (EF) > 40%/absence of congestive heart failure (CHF) 6. Cardiac index > 2.5 L/min/m2 7. Minimal inotropic support (< 3 mcg/kg/min dobutamine) 8. Adequate coagulation profile 9. Adequate urine output (> 100 ml/hr) 10. Primary service and critical care physician agreement Exclusion Criteria: 1. Prior use of clonidine or alpha-antagonists 2. Prior history of intravenous drug abuse (IVDA) or alcohol abuse (ETOH) 3. Evidence of heart block 4. Difficulty with oxygenation/ventilation 5. Renal or hepatic insufficiency 6. Pregnant (positive urine or serum pregnancy test upon admission) 7. Patient received dexmedetomidine > 24 hours |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mechanical Ventilation Time | time from first weaning attempt to successful extubation | No |
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