The Effect of Anesthesia on Cerebral Oxygenation

February 17, 2021 updated by: Ali AKDOĞAN, Karadeniz Technical University

The Effect of Different Anesthesia Techniques on Cerebral Oxygenation in Thoracic Surgery

One-lung ventilation (OLV) may cause negative changes in the oxygenation of cerebral tissue which results in postoperative cognitive dysfunction. The aim of this prospective study was to compare the potential effects of TIVA and inhalation general anesthesia techniques on cerebral tissue oxygenation and postoperative cognitive functions in patients receiving one-lung ventilation in thoracic surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

One-lung ventilation (OLV) is a commonly used technique in thoracic surgeries. In thoracic surgeries performed with OLV, there may be changes in cerebral tissue oxygenation depending on both patient position and anesthetic technique. The effect of cerebral hypoxia on postoperative cognitive functions is controversially. Despite the ISPOCD1 study in which concluded that there were no relationship between the cerebral hypoxy and postoperative cognitive dysfunction (POCD) regional cerebral oxygen saturation decrements during surgery are listed among the POCD When OLV begins, alveolar hypoxia and arteriovenous shunt of deoxygenated blood occur in the dependant lung. And then, hypoxic pulmonary vasoconstriction (HPV) in non-ventilated lung segments occurs with increased mechanical stress. This event lead to significant physiological changes in cardiac output and pulmonary and systemic pressures In OLV, the propofol-based total intravenous anesthesia (TIVA) and inhalation general anesthesia techniques are frequently used. Recent studies have shown that unlike inhalational anesthetics, propofol does not suppress HPV, indeed increases it (Inhalational anesthetic agents reduce cardiac output more than oxygen consumption, causing a decrease in mixed venous partial pressure of oxygen, which stimulates hypoxic pulmonary vasoconstriction . Studies have shown significant reductions in cerebral oxygen saturation in thoracic surgery as a result of severe oxidative stress due to prolonged OLV and hypoxemia due to decreased functional residual capacity of the ventilated lung in the lateral decubitus position Cerebral oximetry is a method used to monitor the cerebral oxygen distribution-consumption balance and regional oxygen saturation (rSO2) in a limited area of the frontal cortex by noninvasively and continuously combining arterial and venous oxygen saturation signals of near-infrared spectroscopy (NIRS), which is a technique developed in the 1970s. Thanks to this method, perioperative physiological conditions, optimal tissue oxygenation and end-organ functions can be interpreted The aim of this prospective study was to compare the potential effects of TIVA and inhalation general anesthesia techniques on cerebral tissue oxygenation and postoperative cognitive functions in patients receiving one-lung ventilation in thoracic surgery

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who would undergo thoracic surgery with one-lung ventilation (OLV)

Description

Inclusion Criteria:

  • Patients in American Society of Anesthesiology (ASA) classification I and II
  • Patients who would undergo thoracic surgery with one-lung ventilation (OLV)
  • thoracic surgeries with one-lung ventilation (OLV) that will take at least 45 minutes

Exclusion Criteria:

  • Patients in ASA classification III and higher
  • Emergency surgery
  • Patients with known allergy to drugs used in the study
  • Patients in New York Heart Association classification III-IV
  • severe metabolic, renal, hepatic, central nervous system diseases, alcohol or drug addiction
  • multiple trauma, coagulapathy, cerebral disease, dementia, hearing impairment and imperception
  • severe obesity (a body mass index (BMI) of ≥ 35)
  • patients with a peripheral oxygen saturation below 90 during one lung ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group Propofol
anesthesia was maintained with TIVA (intravenous 125-250 µg/kg/min propofol + 0.1-0.25 µg/kg/min remifentanil infusion)
Drug: Propofol
BIS values were arranged 40-60 until the end of operation, In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
Other Names:
  • Remifentanil
Group Sevoflurane
anesthesia was maintained with inhalation (sevoflurane concentration of 1-2% in 50-50% O2-air mixture).
Drug: Sevoflurane
Sevoflurane %2-3 for general anesthesia maintenance, BIS values were arranged 40-60 until the end of operation, In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Near Infrared Spectroscopy
Time Frame: Duration of surgery
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Duration of surgery
Mini mental state examination (MMSE)
Time Frame: 3 to 24 hours postoperative period
Mini mental state examination (MMSE) to evaluate patients' cognitive functions
3 to 24 hours postoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mean arterial pressure
Time Frame: Duration of surgery
The effect of anesthetics on mean arterial pressure
Duration of surgery
heart rate
Time Frame: Duration of surgery
The effect of anesthetics on heart rate
Duration of surgery
bispectral index
Time Frame: Duration of surgery
The effects of sevoflurane and desflurane on bispectral index
Duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Cognitive Complications

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings