The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery

The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery Operations Where Single Lung Ventilation is Applied

Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation.

For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially manufactured intubation tubes. This application can disrupt tissue oxygenation due to both Operation position and single lung ventilation.

Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is applied prior to the operation and is provided to assist in postoperative analgesia.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; Epidural Anesthesia; Cerebral Oxygen Saturation
• Intervention / Treatment: Device: Regional oximetry probe; Procedure: Thoracic Epidural block

Detailed Description

The aim of this study was to investigate the effect of thoracic epidural analgesia method on brain tissue oxygenation in patients with single lung ventilation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class
• Underwent Thoracic Surgery

Exclusion Criteria:

• Local anesthetic allergy,
• Bleeding is a diathesis disorder
• Allergic to the drugs used,
• Patients who are not reluctant to participate in the study,
• Presence of infection in the block area,
• Patients whose body mass index is over 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group E; Thoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head	Device: Regional oximetry probe; Regional oximetry probe will be placed in the frontal area of the head; Procedure: Thoracic Epidural block; Thoracic epidural block will be applied to the patients before the operation begins
Sham Comparator: Group P; Regional oximetry probe will be placed in the frontal area of the head	Device: Regional oximetry probe; Regional oximetry probe will be placed in the frontal area of the head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rso2	Regional oximetry probe will be placed in the frontal area of the head	peroperative 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
po2	Arterial blood gas oxygen pressure	peroperative 2 hours
ETCO2	End-tidal carbon dioxide (ETCO2) level	peroperative 2 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Director: Korgün Ökmen, Assoc. PhD., Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: BYIERH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No