CompletedNot applicableNCT00839605
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedDexmedetomidine

The study team can explain what participation involves.

Who it may be forEsophageal Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 4, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Missouri-Columbia

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Missouri-Columbia
Interventions being studied
Drug: Dexmedetomidine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Missouri-ColumbiaColumbia, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2016. Always confirm current availability with the study team.

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