NCT05829785

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

April 13, 2023

Last Update Submit

October 15, 2023

Conditions

ObesityAnesthesiaMicrocirculation

Keywords

ObesityBody mass indexAnesthesia, generalMicrocirculation

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Secondary Outcomes (3)

  • Recovery slope before general aneshtesia (Tpre)

    10 minutes

  • Occlusion slope before general anesthesia (Tpre)

    10 minutes

  • Occlusion slope before general anesthesia (Tpost)

    10 minutes

Study Arms (2)

overweight group

Subjects with a body mass index (BMI) ≥ 25

Device: Near-infrared spectroscopy monitor

normal weight group

Subjects with BMI \< 25

Device: Near-infrared spectroscopy monitor

Interventions

Near-infrared spectroscopy monitorDEVICE

tissue oxygen saturation monitoring combined with vascular occlusion test

normal weight groupoverweight group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects who underwent elective surgery under general anesthesia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33526968BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 26, 2023

Study Start

June 1, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

KR(1)