Status:
COMPLETED
Dose-Response of Adenosine for Perioperative Pain
Lead Sponsor:
Xsira Pharmaceuticals
Conditions:
Perioperative Pain
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by i...
Eligibility Criteria
Inclusion
- Female gender; age 18 to 65 years;
- American Society of Anesthesiology (ASA) physical classification I to III;
- scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;
Exclusion
- ASA physical classification of IV or V;
- documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);
- history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;
- history of gout;
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00298636
Start Date
October 1 2005
Last Update
August 2 2006
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Miami/Miller School of Medicine
Miami, Florida, United States, 33136
3
Medical College of Georgia
Augusta, Georgia, United States, 30912
4
University of Chicago
Chicago, Illinois, United States, 60637