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Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691886
Recruitment Status : Withdrawn (PI left institution prior to enrollment)
First Posted : June 6, 2008
Last Update Posted : May 10, 2012
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:
To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.

Condition or disease Intervention/treatment Phase
Pain Drug: dexmedetomidine hydrochloride Phase 4

Detailed Description:
Dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. Dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. This study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound
Study Start Date : April 2008
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Subjects randomized to arm 1 of the study will recieve standard of care conscious sedation for EBUS; midasolam and or fentanyl.
Active Comparator: 2
Subjects undergoing EBUS randomized to arm 2 of the study will recieve demedetomadine hydrochloride plus standard of care conscious sedation
Drug: dexmedetomidine hydrochloride
Dose of 0.4ug/kg/hr to 1.5ug/kg/hr to achieve a RASS score of -1 to-3 during the bronchoscopy procedure. Dexmedetomidine will infused a half hour before the proceudure is started and will continue throughout the procedure. Traditional sedatives (midazolam and or fentanyl) will be given prn.
Other Name: Precedex

Primary Outcome Measures :
  1. Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion. [ Time Frame: at conclusion of subject enrollemtn ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults between the age of 18 and 85
  • Adults scheduled for flexible brochoscopy using EUBS (Endobronchial Ultrasound)

Exclusion Criteria:

  • Sever bradycardia (rate < 50) and / or related bradydysrhymias (e.g. advanced heart block)
  • Impaired ventricular functions (EF <30%)
  • Hypovolemia or hypotension (SBP <90 or MAP <a55)
  • Have GFR less than 15ml/min 1.73m2 or undergoing hemodialysis
  • Endstage liver disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691886

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United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
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Principal Investigator: David R Riker, MD Lahey Clinic Medical Center
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Responsible Party: Lahey Clinic Identifier: NCT00691886    
Other Study ID Numbers: 2008-011
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Keywords provided by Lahey Clinic:
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action