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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer; Lung Cancer; Chest Wall Disorders
• Intervention / Treatment: 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
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Those patients whom will be receiving thoracic surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: Precedex
placebo; Group having thoracic surgery and not receiving dex drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation	During thoracic surgical procedure

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: joseph tobias, md, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 9, 2009

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Thoracic surgery one lung ventilation; airway reconstruction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 1124100 Hospira

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No