Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

Completed · Not applicable

Conditions studied: Sedation, Flexible Bronchoscopy, COPD

In brief

To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).

Key facts

Study ID

NCT00401206

Run by

The Cooper Health System

People needed

12

Starts

2006-11-01

Expected to finish

2007-06-01

Last updated by the study team

2007-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cooper University Hospital — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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