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Dose-Response of Adenosine for Perioperative Pain

NCT ID: NCT00298636

Last Updated: 2006-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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 inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.

Detailed Description

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Conditions

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Perioperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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adenosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xsira Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Tong J Gan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

University of Miami/Miller School of Medicine

Miami, Florida, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest University/Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Memorial Hermann-Memorial City Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ADO-122

Identifier Type: -

Identifier Source: org_study_id