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

Pain Clinical Trial

Official title:

Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00691886
• Other study ID #: 2008-011
• Status: Withdrawn
• Phase: Phase 4
• First received: June 4, 2008
• Last updated: May 9, 2012
• Start date: April 2008
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.		at conclusion of subject enrollemtn	Yes