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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: dexmedetomidine hydrochloride

• Registration Number: NCT00691886
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.	at conclusion of subject enrollemtn

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States