An observational study in Obesity, Anesthesia and Microcirculation, sponsored by Pusan National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Pusan National University Hospital · Observational
The purpose of this study was to investigate the effect of obesity on changes in microvascular reactivity and tissue oxygen saturation (StO2) during general anesthesia using near-infrared spectroscopy in conjunction with vascular occlusion tests (VOT).
For this prospective observation investigation, a total of 128 patients who underwent elective surgery under general anesthesia at Pusan National University Hospital between June 2018 and February 2021 were participated in this study. Baseline StO2 on thenar eminence, hemodynamics, and laboratory profile were monitored before (Tpre) and 30 min after general anesthesia (Tpost). During vascular occlusion tests (VOT), the occlusion slope representing oxygen consumption of muscle and recovery slope representing microvascular reactivity were also collected at Tpre and Tpost. For analysis, the patients were divided into two groups: overweight (body mass index [BMI] ≥ 25 kg/m2) and normal weight (BMI \< 25).
Preoperative laboratory findings were obtained. Mean blood pressure (MBP), pulse oxygen saturation (SpO2), heart rate (HR), skin temperature, and VOT-derived measurements, including baseline tissue oxygen saturation (StO2), occlusion slope, minimum StO2, time to minimum StO2, recovery slope, maximum StO2, and time to baseline StO2 were recorded before (Tpre) and 30 min after general anesthesia (Tpost).
6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 128 is close to the median of 132 across 1,339 observational studies indexed under Obesity.
Browse Obesity studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who underwent elective surgery under general anesthesia between 2018 and 2021 in Pusan national univ. hospital.
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Exclusion Criteria:
Subjects with a body mass index (BMI) ≥ 25
Device: Near-infrared spectroscopy monitor
Subjects with BMI \< 25
Device: Near-infrared spectroscopy monitor
tissue oxygen saturation monitoring combined with vascular occlusion test
Recovery slope after general aneshtesia (Tpost)
Representing microvascular reactivity (Tpost: 30 minutes after general anesthesia); recovery slope was calculated from deflation of the tourniquet until the recovery of StO2 to the baseline value.
Time frame: 10 minutes
Recovery slope before general aneshtesia (Tpre)
Representing microvascular reactivity (Tpre: before general anesthesia); recovery slope was calculated from deflation of the tourniquet until the recovery of StO2 to the baseline value.
Time frame: 10 minutes
Occlusion slope before general anesthesia (Tpre)
representing oxygen consumption of muscle (Tpre: before general anesthesia); occlusion slope was defined as the slope of StO2 descent to the lowest value.
Time frame: 10 minutes
Occlusion slope before general anesthesia (Tpost)
representing oxygen consumption of muscle (Tpost: 30 minutes after general anesthesia); occlusion slope was defined as the slope of StO2 descent to the lowest value.
Time frame: 10 minutes
Plan to share: Undecided
Ran from Jun 2018 to primary completion in Feb 2021, 32 months.
Of 538 non-industry observational studies under Obesity, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 111. This study's 32 months is below that.
Counting every sponsor, half of 570 studies reached it within 40 months; a quarter within 19 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital