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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04760262
Other study ID # 2013/21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date January 20, 2020

Study information

Verified date February 2021
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 20, 2020
Est. primary completion date June 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Aguirre JA, Märzendorfer O, Brada M, Saporito A, Borgeat A, Bühler 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Near Infrared Spectroscopy Cerebral oxygen saturation as measured by Near Infrared Spectroscopy Duration of surgery
Primary Mini mental state examination (MMSE) Mini mental state examination (MMSE) to evaluate patients' cognitive functions 3 to 24 hours postoperative period
Secondary mean arterial pressure The effect of anesthetics on mean arterial pressure Duration of surgery
Secondary heart rate The effect of anesthetics on heart rate Duration of surgery
Secondary bispectral index The effects of sevoflurane and desflurane on bispectral index Duration of surgery
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