Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease

October 11, 2015 updated by: Yonsei University
COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Above 40 years of age
  2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  3. COPD diagnosed , criteria ( on preop. PFT : FEV1 < 80%, FEV1 / FVC < 70% after bronchodilator)
  4. thoracic surgical procedure

Exclusion Criteria:

  1. severe functional liver or kidney disease
  2. diagnosed HF ( NYHA class >3)
  3. arrhythmia or received treatment with antiarrythmic drug .
  4. exceed BMI > 30 kg/ m2
  5. bradycardia (HR <50 bpm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
saline solution
Drug: saline infusion
saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
Active Comparator: dexmedetomidine group
dexmedetomidine
Drug: dexmedetomidine infusion
dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of the oxygenation
Time Frame: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)
PaO2/FiO2 ratio
At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2014-0306

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