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

This study has been withdrawn prior to enrollment.
(PI left institution prior to enrollment)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00691886
First received: June 4, 2008
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Pain
Drug: dexmedetomidine hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691886

Locations
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: David R Riker, MD Lahey Clinic Medical Center
  More Information

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00691886     History of Changes
Other Study ID Numbers: 2008-011
Study First Received: June 4, 2008
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
sedation

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014