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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00464490 |
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.
Condition | Intervention |
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Extubation Respiration Disorders |
Drug: Dexmedetomidine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Arms | Assigned Interventions |
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1: No Intervention
Control. Hospital weaning protocol
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2: Active Comparator
Intervention: Use Dexmedetomidine to facilitate extubation.
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Drug: Dexmedetomidine
Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine will be titrated according to blood pressure, RASS and heart rate response and the dose will be lowered only after sedation is discontinued or markedly reduced.
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Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julin F Tang, M.D., M.S. | (415) 206-5274 | tangj@anesthesia.ucsf.edu |
Contact: Mariah S Call, B.S. | (415) 206-5275 | callm@anesthesia.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Julin F Tang, M.D., M.S. 415-206-5274 tangj@anesthesia.ucsf.edu | |
Contact: Mariah S Call, B.S. (415) 206-5275 callm@anesthesia.ucsf.edu |
Principal Investigator: | Julin F Tang, M.D., M.S. | University of California, San Francisco |
Study ID Numbers: | 0703054 |
Study First Received: | April 19, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00464490 |
Health Authority: | United States: Institutional Review Board |
Weaning Extubation Dexmedetomidine To test if dexmedetomidine facilitates weaning and extubation in patients who have failed previous attempts. |
Respiratory Tract Diseases Respiration Disorders Dexmedetomidine |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Adrenergic Agonists |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents |