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

Lahey Health

Status and phase: Withdrawn; Phase 4

Conditions: Pain

Treatments: Drug: dexmedetomidine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00691886

2008-011

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

No Intervention group

Description:

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

2

Active Comparator group

Description:

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

Treatment:

Drug: dexmedetomidine hydrochloride