Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation

October 12, 2016 updated by: Seoul National University Hospital
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate during one-lung ventilation in the perspective of oxygenation and microcirculation. The investigators hypothesized that intravenous and inhalational anesthetics may affect oxygenation and microcirculation differently during one-lung ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing thoracic surgery including one-lung ventilation will be randomized to receive intravenous (propofol) or inhalational (desflurane) anesthetic.

Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare arterial partial pressure of oxygen and recovery slope during one-lung ventilation between propofol and desflurane group.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing thoracic surgery including one-lung ventilation

Exclusion Criteria:

  • refuse to enroll
  • BMI over 30 kg/m(2)
  • severe obstructive or restrictive lung disease
  • preoperative supplemental oxygen, intubated, or mechanical ventilatory support
  • preoperative arterial partial pressure of oxygen < 60 mmHg
  • pregnancy
  • history of coronary artery disease
  • preoperative continuous infusion of vasopressor or inotropes
  • cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propofol
Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4~5 mcg/ml, during general anesthesia
Drug: propofol
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
Other Names:
  • propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)
Experimental: desflurane

Desflurane is used as a maintenance anesthetic to patients in the desflurane group.

Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6~8 vol% during general anesthesia
Drug: desflurane
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
Other Names:
  • desflurane (Suprane(R), Baxter Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial partial pressure of oxygen
Time Frame: 30 min after one-lung ventilation
Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
30 min after one-lung ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recovery slope
Time Frame: 30 min after one-lung ventilation
Secondary outcome is recovery slope measured by vascular occlusion test 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
30 min after one-lung ventilation

Other Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 30 min after one-lung ventilation
30 min after one-lung ventilation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 13, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PaO2 & StO2 in OLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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