Clinical trial NCT05829785: Influence of Obesity on Microvascular Reactivity During General Anesthesia
Official title: Influence of Obesity on Microvascular Reactivity During General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Anesthesia
Microcirculation
Keywords: Obesity
Body mass index
Anesthesia, general
Microcirculation
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent elective surgery under general anesthesia between 2018 and 2021 in Pusan national univ. hospital.

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent elective surgery under general anesthesia.

Exclusion Criteria:

* Society of Anesthesiologists (ASA) physical status \> II
* patients with a neuraxial block
* uncontrolled hypertension
* patients with major cardiovascular disease
* diabetes
* pregnant individuals
* peripheral vascular disease
* chronic venous insufficiency
* smoking: Pack-years \> 10
* chronic obstructive and restrictive pulmonary disease

Primary outcomes:
measure: Recovery slope after general aneshtesia (Tpost)
timeFrame: 10 minutes
Secondary outcomes:
measure: Recovery slope before general aneshtesia (Tpre)
timeFrame: 10 minutes
measure: Occlusion slope before general anesthesia (Tpre)
timeFrame: 10 minutes
measure: Occlusion slope before general anesthesia (Tpost)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
References:
citation: Cho AR, Lee HJ, Kim HJ, Do W, Jeon S, Baek SH, Kim ES, Kwon JY, Kim HK. Microvascular Reactivity Measured by Dynamic Near-infrared Spectroscopy Following Induction of General Anesthesia in Healthy Patients: Observation of Age-related Change. Int J Med Sci. 2021 Jan 1;18(5):1096-1103. doi: 10.7150/ijms.52433. eCollection 2021.