Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Lahey Clinic
- Locations
- 1
- Primary Endpoint
- Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
2
Subjects undergoing EBUS randomized to arm 2 of the study will recieve demedetomadine hydrochloride plus standard of care conscious sedation
Intervention: dexmedetomidine hydrochloride (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported