The Change of Tissue Oxygen Saturation Following Volatile Anesthesia

NCT03060798 | Completed DMC FDA Drug FDA Device

• 1 other identifier: 1607-012-054
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Aging

Outcome Measures

Primary Outcomes (1)

• Changes in Tissue Oxygen Saturation after General Anesthesia

  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.

  before and 30 minutes after anesthetic induction

Secondary Outcomes (1)

• Age-related changes in microcirculation

  before and 30 minutes after anesthetic induction

Interventions

Desflurane DRUG

general anesthesia using desflurane.

Also known as: suprane

Near-infrared spectroscopy monitor DEVICE

tissue oxygen saturation monitoring combined with vessel occlusion test

Also known as: tissue oxygen saturation monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult male and female patients over 18 years of age undergoing general surgery under general anesthesia. American anesthesiologists association patient (ASA) category I or II.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Hyeon Jeong Lee

Busan, 49241, South Korea

Location

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Hyeon-Jeong Lee, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: August 2, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)