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Study on the Use of Dexmedetomidine to Facilitate Extubation in Surgical Intensive-Care-Unit Patients Who Failed Previous Weaning Attempts
This study is currently recruiting participants.
Verified by University of California, San Francisco, May 2008
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00464490
  Purpose

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
Extubation
Respiration Disorders
Drug: Dexmedetomidine

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources
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

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 60
Study Start Date: November 2007
Arms Assigned Interventions
1: No Intervention
Control. Hospital weaning protocol
2: Active Comparator
Intervention: Use Dexmedetomidine to facilitate extubation.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464490

Contacts
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

Locations
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    
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Julin F Tang, M.D., M.S. University of California, San Francisco
  More Information

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

Keywords provided by University of California, San Francisco:
Weaning
Extubation
Dexmedetomidine
To test if dexmedetomidine facilitates weaning and extubation in patients who have failed previous attempts.

Study placed in the following topic categories:
Respiratory Tract Diseases
Respiration Disorders
Dexmedetomidine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009