Influence of Obesity on Microvascular Reactivity During General Anesthesia

October 15, 2023 updated by: Hyeon-Jeong Lee, Pusan National University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who underwent elective surgery under general anesthesia between 2018 and 2021 in Pusan national univ. hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
overweight group
Subjects with a body mass index (BMI) ≥ 25
Device: Near-infrared spectroscopy monitor
tissue oxygen saturation monitoring combined with vascular occlusion test
normal weight group
Subjects with BMI < 25
Device: Near-infrared spectroscopy monitor
tissue oxygen saturation monitoring combined with vascular occlusion test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes
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.
10 minutes
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0175 (M D Anderson Cancer Center)
  • 1804-025-066 (Other Identifier: Pusan national university hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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