- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060798
The Change of Tissue Oxygen Saturation Following Volatile Anesthesia
The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population
General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.
This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.
Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Busan, Korea, Republic of, 49241
- Hyeon Jeong Lee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult Over 18 years of age undergoing general surgery under general anesthesia.
Exclusion Criteria:
- ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Tissue Oxygen Saturation after General Anesthesia
Time Frame: before and 30 minutes after anesthetic induction
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Vascular occlusion test (VOT) will be performed twice for each patient, before (T0) and 30 min after the induction of general anesthesia (T1).
Before induction, a NIRS sensor will be placed on the thenar eminence and an automated tourniquet will be placed around the ipsilateral upper arm.
After the baseline StO2 stabilization, the automatic tourniquet will be inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintain for 5 min.
After the 5-min ischemic period, the tourniquet will be rapidly deflated to 0 mmHg.
StO2 data will be continuously recorded during the VOT procedure.
Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, maximum StO2 during deflation of the tourniquet, time to minimum StO2, and time to maximum StO2 will be obtained.
The occlusion slope and recovery slope will be calculated based on the measured StO2 data.
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before and 30 minutes after anesthetic induction
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age-related changes in microcirculation
Time Frame: before and 30 minutes after anesthetic induction
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Patients will be divided into three groups by age (younger group: < 65 years old and older group: ≥ 65 years old) to perform age-based analysis.
The acquired StO2 data by the VOT test among the groups will be analyzed and compared.
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before and 30 minutes after anesthetic induction
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Collaborators and Investigators
Investigators
- Principal Investigator: Hyeon-Jeong Lee, PhD, Pusan National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1607-012-054
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.
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