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

NCT ID: NCT04373174

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thoracic Surgery Epidural Anesthesia Cerebral Oxygen Saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective,randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group E

Thoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head

Group Type ACTIVE_COMPARATOR

Regional oximetry probe

Intervention Type DEVICE

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

Thoracic Epidural block

Intervention Type PROCEDURE

Thoracic epidural block will be applied to the patients before the operation begins

Group P

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

Group Type SHAM_COMPARATOR

Regional oximetry probe

Intervention Type DEVICE

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

Interventions

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Regional oximetry probe

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

Intervention Type DEVICE

Thoracic Epidural block

Thoracic epidural block will be applied to the patients before the operation begins

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Principal Investigator ,Assoc. PhD. M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Korgün Ökmen, Assoc. PhD.

Role: STUDY_DIRECTOR

Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Locations

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Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BYIERH

Identifier Type: -

Identifier Source: org_study_id

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