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

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ClinicalTrials.gov Identifier: NCT00839605
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Missouri-Columbia

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 ventilation.


Condition or disease Intervention/treatment
Esophageal Cancer Lung Cancer Chest Wall Disorders Drug: Dexmedetomidine

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 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.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedure and One-Lung Ventilation(OLV)
Study Start Date : March 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Dexmedetomidine
Those requiring thoracic surgery and receiving dex
Drug: Dexmedetomidine
loading dose:0.3mcg/kg. Infusion of 0.3mcg/kg/hr
Other Name: Precedex

placebo
Group having thoracic surgery and not receiving dex drug



Primary Outcome Measures :
  1. The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation [ Time Frame: During thoracic surgical procedure ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Those patients whom will be receiving thoracic surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839605


Locations
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: joseph tobias, md University of Missouri-Columbia

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00839605     History of Changes
Other Study ID Numbers: 1124100 Hospira
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Thoracic surgery one lung ventilation
airway reconstruction

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action