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

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04373174
Collaborator
(none)
60
1
2
12.5
4.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Regional oximetry probe
  • Procedure: Thoracic Epidural block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective,randomizedprospective,randomized
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery Operations Where Single Lung Ventilation is Applied
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. rso2 [peroperative 2 hours]

    Regional oximetry probe will be placed in the frontal area of the head

Secondary Outcome Measures

  1. po2 [peroperative 2 hours]

    Arterial blood gas oxygen pressure

  2. ETCO2 [peroperative 2 hours]

    End-tidal carbon dioxide (ETCO2) level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Yuksek Ihtisas Training and Research Hospital Bursa Turkey 16110

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korgün Ökmen, Principal Investigator ,Assoc. PhD. M.D., Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT04373174
Other Study ID Numbers:
  • BYIERH
First Posted:
May 4, 2020
Last Update Posted:
May 5, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2020