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

NCT00839605

Last updated date
Study Location
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Cancer, Lung Cancer, Chest Wall Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Esophageal Cancer, Lung Cancer, Chest Wall DisordersDexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedures and One-Lung Ventilation
NCT00839605
  1. Columbia, Missouri
ALL GENDERS
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedures and One-Lung Ventilation
Official Title Dexmedetomidine and Hypoxic Pulmonary Vasoconstriction in Thoracic Surgical Procedure and One-Lung Ventilation(OLV)
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Those patients whom will be receiving thoracic surgery
Condition
  • Esophageal Cancer
  • Lung Cancer
  • Chest Wall Disorders
Intervention Drug: Dexmedetomidine
loading dose:0.3mcg/kg. Infusion of 0.3mcg/kg/hr
Other Name: Precedex
Study Groups/Cohorts
  • Dexmedetomidine
    Those requiring thoracic surgery and receiving dex
    Intervention: Drug: Dexmedetomidine
  • placebo
    Group having thoracic surgery and not receiving dex drug
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2010)
25
Original Estimated Enrollment
 (submitted: February 6, 2009)
20
Actual Study Completion Date November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00839605
Other Study ID Numbers 1124100 Hospira
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party University of Missouri-Columbia
Study Sponsor University of Missouri-Columbia
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator:joseph tobias, mdUniversity of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date October 2016