Status:
COMPLETED
Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedures and One-Lung Ventilation
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Esophageal Cancer
Lung Cancer
Eligibility:
All Genders
19+ years
Brief Summary
The purpose of this study is to evaluate the effects of Dexmedetomidine when used during thoracic surgery. The primary outcome will be changes in oxygenation as measured the PaO2 during one lung vent...
Detailed Description
To collect data on the effects of Dexmedetomidine(DEX)(0.3mcg/kg loading dose followed by an infusion of 0.3mcg/kg/hr)on Hypoxic pulmonary vasoconstriction when administered to patients during surgery...
Eligibility Criteria
Inclusion
- Subject is \> 18 years of age.
- Subject is American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
- If female, subject is non-lactating and is either:
- Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- Subject requires thoracic surgical procedure .
- Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.
Exclusion
- Subject has received general anesthesia within 7 days prior to study entry, has received any experimental drug within 30 days prior to study drug administration, or has been previously enrolled in this study.
- Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment.
- Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
- Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
- Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, of the start of study drug administration.
- Subject has acute unstable angina, acute myocardial infarction documented by laboratory findings in the past six weeks, heart rate \< 50 bpm, SBP \< 90 mmHg, or third-degree heart block unless patient has a pacemaker.
- Subject has known elevated SGPT (ALT) and/or SGOT (AST) values of \> 2 times the upper limit of normal (ULN) within the two months prior to screening, and/or a history of liver failure.
- Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
- On vasodilators, i.e.,nitroglycerin, nitroprusside, or ACE inhibitors
- on vasopressors, i.e, norepinephrine,epinephrine, or vasopressin
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00839605
Start Date
March 1 2009
End Date
November 1 2009
Last Update
October 4 2016
Active Locations (1)
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1
University of Missouri-Columbia
Columbia, Missouri, United States, 65212