Status:
COMPLETED
Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study
Lead Sponsor:
The Cooper Health System
Conditions:
Sedation
Flexible Bronchoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).
Detailed Description
This is a pilot study designed to provide preliminary data on the use of dexmedetomidine for outpatient FB procedures requiring sedation. Clinical parameters such as vital signs, level of sedation, do...
Eligibility Criteria
Inclusion
- Subject has COPD
- Subject is ≥ 18 years of age
- If female, subject is non-lactating and either not able to become pregnant or proven not to be pregnant and actively practicing birth control
- Subject or subject's legally authorized representative has voluntarily signed and dated an informed consent after all has been explained and any/all questions answered
Exclusion
- Subject for whom α2 agonists are contraindicated
- Subject for whom opiates, benzodiazepines, or dexmedetomidine are contraindicated or who has known or suspected serious allergy to any drug that might be administered during the course of the study
- Subject meets any of the following cardiovascular criteria:
- (A routine EKG will be performed for potential subjects prior to enrollment in order to screen for unrecognized conduction abnormalities.)
- Acute unstable angina (defined during current hospital stay)
- Myocardial infarction within 6 weeks of bronchoscopy
- Suspicion of acute myocardial infarction
- Known severe left ventricular failure
- Heart rate \< 50 bpm prior to infusion start
- Systolic blood pressure less than 90 mmHg prior to infusion start
- Conduction abnormalities except 1st degree AV block and rate-controlled atrial fibrillation; subjects with functional pacemaker capacity can be enrolled
- Known severe liver disease
- Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD)
- Subject has a known, uncontrolled seizure disorder
- Subject on α-agonists or blockers
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00401206
Start Date
November 1 2006
End Date
June 1 2007
Last Update
November 5 2007
Active Locations (1)
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1
Cooper University Hospital
Camden, New Jersey, United States, 08103