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

NCT00401206 | Completed

• 1 other identifier: RP-06078
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Sedation; Flexible Bronchoscopy; COPD

Keywords

dexmedetomidine; sedation; bronchoscopy; COPD

Outcome Measures

Primary Outcomes (3)

• Safety and efficacy

• Level of sedation

• Pain rating

Secondary Outcomes (2)

• Drug dosing

• Supplemental sedation

Interventions

dexmedetomidine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wissam Abouzgheib, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2006
• Study Completion: June 1, 2007
• Last Updated: November 5, 2007

Record last verified: 2007-11

Locations

US (1)