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Sponsored by: |
The Cooper Health System |
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Information provided by: | The Cooper Health System |
ClinicalTrials.gov Identifier: | NCT00401206 |
To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).
Condition | Intervention |
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Sedation Flexible Bronchoscopy COPD |
Drug: dexmedetomidine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study |
Enrollment: | 12 |
Study Start Date: | November 2006 |
Study Completion Date: | June 2007 |
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, dosing and supplemental sedation, and measures of comfort will be evaluated in a population of patients with known Chronic Obstructive Lung Disease undergoing elective FB. Patients with COPD scheduled for outpatient FB will be provided with an intravenous infusion of dexmedetomidine (1 mcg/kg/hr) (Precedex®: Hospira, Inc, Lake Forest, IL) over a 15-30 min period before the procedure and continued throughout the procedure. No loading dose will be used prior to start of infusion. The FB procedure will be conducted according to standard practice using routine monitoring technique.
This dosing regimen of 1.0 mcg/kg/hr was chosen because the loading dose will be omitted and since a previous review have documented a lack of adverse events with maintenance doses exceeding 1 mcg/kg/hr. Drug infusion will be discontinued if any of the following adverse events are observed: recurrent apnea (Respiratory Rate <7) lasting more than 30 seconds over a 5 min observation period, sustained episodes (30 seconds) hemoglobin oxygen saturation lower than 90% over a 5 min observation period, decrease of heart rate to below 50 beats/min, mean arterial pressure below 70% of its initial value.
If needed, additional sedation will be provided with alternating doses of midazolam 1 mg, or Fentanyl 25 mcg for pain, agitation interfering with the completion of the procedure, or for persistent cough non-responsive to local lidocaine instillation. The amount of Fentanyl and versed used as an adjunct for conscious sedation will also be recorded as part of this study. The quality of sedation will be assessed using the Richmond Agitation Sedation Scale. The quality of analgesia will be assessed using the 11-point (0-10) Numerical Pain Rating scale (NRS). The level of recovery from anesthesia and the return of psychomotor fitness will be assessed using the Modified Post anesthesia Discharge Scoring System (MPADSS). The duration of FB and the time from the end of the procedure to the patient reaching a score of 9 and 10 on the MPADSS (readiness for discharge) will also be measured. Except for the measurements described above (NRS), no additional procedures will be performed for the purposes of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.)
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 |
Principal Investigator: | Wissam Abouzgheib, MD | The Cooper Health System |
Study ID Numbers: | RP-06078 |
Study First Received: | November 17, 2006 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00401206 History of Changes |
Health Authority: | United States: Institutional Review Board |
dexmedetomidine sedation bronchoscopy COPD |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Central Nervous System Depressants Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases |
Analgesics, Non-Narcotic Lung Diseases Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Pulmonary Disease, Chronic Obstructive |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Adrenergic Agonists Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases |
Sensory System Agents Analgesics, Non-Narcotic Lung Diseases Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Central Nervous System Agents Pulmonary Disease, Chronic Obstructive |