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NCT Number: NCT03060798

The Change of Tissue Oxygen Saturation Following Volatile Anesthesia

General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.

This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.

Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.

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Key information

Conditions

Healthy Aging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hyeon Jeong Lee

Busan, 49241, South Korea

About this study

This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (< 65 yrs) and old (> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Over 18 years of age undergoing general surgery under general anesthesia.

Exclusion criteria

  • ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease

Treatment and study plan

Desflurane

Drug

general anesthesia using desflurane.

Other names: suprane

Near-infrared spectroscopy monitor

Device

tissue oxygen saturation monitoring combined with vessel occlusion test

Other names: tissue oxygen saturation monitor

Primary outcomes

  1. Changes in Tissue Oxygen Saturation after General Anesthesia

    Time frame: before and 30 minutes after anesthetic induction

    Vascular occlusion test (VOT) will be performed twice for each patient, before (T0) and 30 min after the induction of general anesthesia (T1). Before induction, a NIRS sensor will be placed on the thenar eminence and an automated tourniquet will be placed around the ipsilateral upper arm. After the baseline StO2 stabilization, the automatic tourniquet will be inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintain for 5 min. After the 5-min ischemic period, the tourniquet will be rapidly deflated to 0 mmHg. StO2 data will be continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, maximum StO2 during deflation of the tourniquet, time to minimum StO2, and time to maximum StO2 will be obtained. The occlusion slope and recovery slope will be calculated based on the measured StO2 data.

Secondary outcomes

  1. Age-related changes in microcirculation

    Time frame: before and 30 minutes after anesthetic induction

    Patients will be divided into three groups by age (younger group: < 65 years old and older group: ≥ 65 years old) to perform age-based analysis. The acquired StO2 data by the VOT test among the groups will be analyzed and compared.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Apr 14, 2020

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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