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
  Purpose

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 Intervention
Lung,Esophageal Cancers
Airway Reconstruction
Chest Wall Disorders
Drug: Dexmedetomidine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedure and One-Lung Ventilation(OLV)

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dex group
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839605

Locations
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Hospira, Inc.
Investigators
Principal Investigator: joseph tobias, md University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Joseph Tobias, MD, University of Missouri
ClinicalTrials.gov Identifier: NCT00839605     History of Changes
Other Study ID Numbers: 1124100 Hospira
Study First Received: February 5, 2009
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

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

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 16, 2014