The Effect of Regional Anesthesia Techniques on Brain Tis... | NCT04373174

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

Apr 30, 2020

First Posted Date

May 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2023

Last Update Posted Date

Jan 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Korgün Ökmen, Principal Investigator ,Assoc. PhD. M.D., Bursa Yuksek Ihtisas Training and Research HospitalPrincipal Investigator

Lead Sponsor

Bursa Yuksek Ihtisas Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group E	Active Comparator	Thoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head	Device: Regional oximetry probe Procedure: Thoracic Epidural block
Group P	Sham Comparator	Regional oximetry probe will be placed in the frontal area of the head	Device: Regional oximetry probe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regional oximetry probe	Device	Regional oximetry probe will be placed in the frontal area of the head	Group E Group P

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Korgün Ökmen, Assoc. PhD.	Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa Yuksek Ihtisas Training and Research Hospital		Bursa		16110	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.