Influence of Obesity on Microvascular Reactivity During General Anesthesia

NCT ID: NCT05829785

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-02-28

Brief Summary

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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

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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).

Conditions

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Obesity Anesthesia Microcirculation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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overweight group

Subjects with a body mass index (BMI) ≥ 25

Near-infrared spectroscopy monitor

Intervention Type DEVICE

tissue oxygen saturation monitoring combined with vascular occlusion test

normal weight group

Subjects with BMI \< 25

Near-infrared spectroscopy monitor

Intervention Type DEVICE

tissue oxygen saturation monitoring combined with vascular occlusion test

Interventions

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Near-infrared spectroscopy monitor

tissue oxygen saturation monitoring combined with vascular occlusion test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyeon-Jeong Lee

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 33526968 (View on PubMed)

Other Identifiers

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1804-025-066

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0175

Identifier Type: -

Identifier Source: org_study_id

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