The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2021
CompletedJanuary 10, 2023
January 1, 2023
11 months
April 30, 2020
January 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
rso2
Regional oximetry probe will be placed in the frontal area of the head
peroperative 2 hours
Secondary Outcomes (2)
po2
peroperative 2 hours
ETCO2
peroperative 2 hours
Study Arms (2)
Group E
ACTIVE COMPARATORThoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head
Group P
SHAM COMPARATORRegional oximetry probe will be placed in the frontal area of the head
Interventions
Regional oximetry probe will be placed in the frontal area of the head
Thoracic epidural block will be applied to the patients before the operation begins
Eligibility Criteria
You may qualify if:
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent Thoracic Surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110, Turkey (Türkiye)
Study Officials
- STUDY DIRECTOR
Korgün Ökmen, Assoc. PhD.
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator ,Assoc. PhD. M.D.
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 4, 2020
Study Start
May 1, 2020
Primary Completion
April 1, 2021
Study Completion
May 15, 2021
Last Updated
January 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share