- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191371
Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
Other Names:
|
|
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 |
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
Other Names:
|
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.