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Completed

NCT Number: NCT05829785

Influence of Obesity on Microvascular Reactivity During General Anesthesia

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).

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Key information

Conditions

Obesity Anesthesia Body Weight Microcirculation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hospital

Busan, 49241, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-infrared spectroscopy monitor

Device

tissue oxygen saturation monitoring combined with vascular occlusion test

Primary outcomes

  1. Recovery slope after general aneshtesia (Tpost)

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Recovery slope before general aneshtesia (Tpre)

    Time frame: 10 minutes

    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.

  2. Occlusion slope before general anesthesia (Tpre)

    Time frame: 10 minutes

    representing oxygen consumption of muscle (Tpre: before general anesthesia); occlusion slope was defined as the slope of StO2 descent to the lowest value.

  3. Occlusion slope before general anesthesia (Tpost)

    Time frame: 10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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