Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedures and One-Lung Ventilation (Dex-One-Lung)

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00839605
First received: February 5, 2009
Last updated: February 1, 2010
Last verified: February 2010

February 5, 2009
February 1, 2010
March 2009
November 2009   (final data collection date for primary outcome measure)
The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation [ Time Frame: During thoracic surgical procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00839605 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedures and One-Lung Ventilation
Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedure and One-Lung Ventilation(OLV)

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 ventilation.

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 with one lung ventilated thoracic procedures. Dexmedetomidine has both vasoconstricting and vasodilatatory effect on peripheral vasculature but its effect on pulmonary vessels is not known. If it is predominantly a vasodilator on pulmonary vessels it can inhibit hypoxic pulmonary vasoconstriction and will increase shunting of venous blood to arterial circulation without oxygenation. If our study proves it to be a vasodilator for pulmonary vessels then it will not be wise to use it in thoracic procedure with one lung ventilation. If our study proves that it is a vasoconstrictor for pulmonary vessels, then it will be an excellent adjunct to other anesthetic agents during one lung ventilation.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Those patients whom will be receiving thoracic surgery

  • Lung,Esophageal Cancers
  • Airway Reconstruction
  • Chest Wall Disorders
Drug: Dexmedetomidine
loading dose:0.3mcg/kg. Infusion of 0.3mcg/kg/hr
Other Name: Precedex
  • dex group
    Those requiring thoracic surgery and receiving dex
    Intervention: Drug: Dexmedetomidine
  • placebo
    Group having thoracic surgery and not receiving dex drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is > 18 years of age.
  2. Subject is American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
  3. 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.
  4. Subject requires thoracic surgical procedure .
  5. Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
  4. Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
  5. Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, of the start of study drug administration.
  6. 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.
  7. 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.
  8. Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
  9. On vasodilators, i.e.,nitroglycerin, nitroprusside, or ACE inhibitors
  10. on vasopressors, i.e, norepinephrine,epinephrine, or vasopressin
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00839605
1124100 Hospira
No
Joseph Tobias, MD, University of Missouri
University of Missouri-Columbia
Hospira, Inc.
Principal Investigator: joseph tobias, md University of Missouri-Columbia
University of Missouri-Columbia
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP