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

Purpose

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
Sedation Flexible Bronchoscopy COPD	Drug: dexmedetomidine


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

Resource links provided by NLM:

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by The Cooper Health System:

Primary Outcome Measures:

Safety and efficacy
Level of sedation
Pain rating

Secondary Outcome Measures:

Drug dosing
Supplemental sedation


Enrollment:	12
Study Start Date:	November 2006
Study Completion Date:	June 2007

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, 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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401206

Locations


United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103

Sponsors and Collaborators

The Cooper Health System

Investigators


Principal Investigator:	Wissam Abouzgheib, MD	The Cooper Health System

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00401206 History of Changes
Other Study ID Numbers:	RP-06078
Study First Received:	November 17, 2006
Last Updated:	November 2, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cooper Health System:


dexmedetomidine sedation bronchoscopy COPD

Additional relevant MeSH terms:


Dexmedetomidine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Analgesics Analgesics, Non-Narcotic Central Nervous System Agents Central Nervous System Depressants	Hypnotics and Sedatives Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015