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

NCT00691886 | Withdrawn Phase 4

• 1 other identifier: 2008-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

sedation

Outcome Measures

Primary Outcomes (1)

• Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.

  at conclusion of subject enrollemtn

Study Arms (2)

1

NO INTERVENTION

Subjects randomized to arm 1 of the study will recieve standard of care conscious sedation for EBUS; midasolam and or fentanyl.

2

ACTIVE COMPARATOR

Subjects undergoing EBUS randomized to arm 2 of the study will recieve demedetomadine hydrochloride plus standard of care conscious sedation

Drug: dexmedetomidine hydrochloride

Interventions

dexmedetomidine hydrochloride DRUG

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.

Also known as: Precedex

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David R Riker, MD

  Lahey Clinic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)