Influence of Obesity on Microvascular Reactivity During General Anesthesia

Obesity Clinical Trial

Official title:

Influence of Obesity on Microvascular Reactivity During General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05829785
• Other study ID #: 2018-0175
• Secondary ID: 1804-025-066
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2023
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Microcirculation
• Obesity

Intervention

Device:
• Near-infrared spectroscopy monitor
tissue oxygen saturation monitoring combined with vascular occlusion test

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recovery slope before general aneshtesia (Tpre)	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
Secondary	Occlusion slope before general anesthesia (Tpre)	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
Secondary	Occlusion slope before general anesthesia (Tpost)	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