Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study
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|ClinicalTrials.gov Identifier: NCT00401206|
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : November 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Sedation Flexible Bronchoscopy COPD||Drug: dexmedetomidine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||June 2007|
- Safety and efficacy
- Level of sedation
- Pain rating
- Drug dosing
- Supplemental sedation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401206
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Wissam Abouzgheib, MD||The Cooper Health System|