Status:
COMPLETED
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
Lead Sponsor:
Dayton VA Medical Center
Conditions:
COPD
Sedation
Eligibility:
All Genders
45-70 years
Phase:
PHASE4
Brief Summary
A variety of medications have been used to treat the anxiety, discomfort, and fear associated with continuous and sudden episodic breathlessness in patients with advanced respiratory disease. Opioids ...
Eligibility Criteria
Inclusion
- Severe COPD (FEV1 30-50% predicted)
- Age 45-70
- American Society of Anesthesiologists (ASA) Class 3
- Body Mass Index \<35 kg/meter squared
- No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)
- Women of non-child bearing age
Exclusion
- known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists
- not nothing by mouth (NPO)
- ASA class \>3
- Home oxygen therapy \>2LPM by nasal cannula continuous use
- Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration
- Pregnancy, or possibility of pregnancy
- Coronary heart disease with stable or unstable angina
- Baseline heart rate \<55 beats per minute
- Bradyarrhythmia, heart block, presence of pacemaker
- Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction \<40% by ECHO, MUGA, or myocardial perfusion imaging)
- Cor pulmonale
- Liver disease (hepatic transaminases above the upper limit of normal, cirrhosis, end stage liver disease)
- diagnosis of moderate to severe Obstructive Sleep Apnea
- currently enrolled in any other research study involving drugs or devices
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02211118
Start Date
October 1 2014
End Date
April 1 2016
Last Update
July 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dayton VA Medical Center
Dayton, Ohio, United States, 45428