- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760262
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
Completed
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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Trabzon, Turkey, 61080
- Karadeniz Technical University
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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
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 |
Intervention / Treatment |
|---|---|
|
Group Propofol
anesthesia was maintained with TIVA (intravenous 125-250 µg/kg/min propofol + 0.1-0.25 µg/kg/min remifentanil infusion)
|
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:
|
|
Group Sevoflurane
anesthesia was maintained with inhalation (sevoflurane concentration of 1-2% in 50-50% O2-air mixture).
|
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
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean arterial pressure
Time Frame: Duration of surgery
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The effect of anesthetics on mean arterial pressure
|
Duration of surgery
|
|
heart rate
Time Frame: Duration of surgery
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The effect of anesthetics on heart rate
|
Duration of surgery
|
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bispectral index
Time Frame: Duration of surgery
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The effects of sevoflurane and desflurane on bispectral index
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Duration of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6. doi: 10.1093/bja/aep309.
- Hood R, Budd A, Sorond FA, Hogue CW. Peri-operative neurological complications. Anaesthesia. 2018 Jan;73 Suppl 1:67-75. doi: 10.1111/anae.14142.
- Nakayama M, Murray PA. Ketamine preserves and propofol potentiates hypoxic pulmonary vasoconstriction compared with the conscious state in chronically instrumented dogs. Anesthesiology. 1999 Sep;91(3):760-71. doi: 10.1097/00000542-199909000-00029.
- Mahal I, Davie SN, Grocott HP. Cerebral oximetry and thoracic surgery. Curr Opin Anaesthesiol. 2014 Feb;27(1):21-7. doi: 10.1097/ACO.0000000000000027.
- Aguirre JA, Marzendorfer O, Brada M, Saporito A, Borgeat A, Buhler P. Cerebral oxygenation in the beach chair position for shoulder surgery in regional anesthesia: impact on cerebral blood flow and neurobehavioral outcome. J Clin Anesth. 2016 Dec;35:456-464. doi: 10.1016/j.jclinane.2016.08.035. Epub 2016 Oct 18.
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)
March 1, 2017
Primary Completion (Actual)
June 15, 2019
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
February 10, 2021
First Submitted That Met QC Criteria
February 17, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Postoperative Complications
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Remifentanil
- Propofol
- Sevoflurane
Other Study ID 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.
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