NCT00839605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

February 5, 2009

Last Update Submit

October 3, 2016

Conditions

Esophageal CancerLung CancerChest Wall Disorders

Keywords

Thoracic surgery one lung ventilationairway reconstruction

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be changes in oxygenation measured by the PaO2 during one lung ventilation

    During thoracic surgical procedure

Study Arms (2)

Dexmedetomidine

Those requiring thoracic surgery and receiving dex

Drug: Dexmedetomidine

placebo

Group having thoracic surgery and not receiving dex drug

Interventions

DexmedetomidineDRUG

loading dose:0.3mcg/kg. Infusion of 0.3mcg/kg/hr

Also known as: Precedex
Dexmedetomidine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Those patients whom will be receiving thoracic surgery

You may qualify if:

  • Subject is \> 18 years of age.
  • Subject is American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
  • 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.
  • Subject requires thoracic surgical procedure .
  • Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.

You may not qualify if:

  • 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.
  • 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.
  • Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
  • Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
  • Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, of the start of study drug administration.
  • 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.
  • 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.
  • Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
  • On vasodilators, i.e.,nitroglycerin, nitroprusside, or ACE inhibitors
  • on vasopressors, i.e, norepinephrine,epinephrine, or vasopressin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsLung Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • joseph tobias, md

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)