The Effect of Anesthesia on Cerebral Oxygenation

NCT04760262 | Completed

• 1 other identifier: 2013/21
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

One-Lung Ventilation; Thoracic Surgery; Postoperative Cognitive Complications

Keywords

One-lung ventilation; cerebral oxygenation; postoperative cognitive dysfunction; sevoflurane; propofol

Outcome Measures

Primary Outcomes (2)

• Near Infrared Spectroscopy

  Cerebral oxygen saturation as measured by Near Infrared Spectroscopy

  Duration of surgery

• Mini mental state examination (MMSE)

  Mini mental state examination (MMSE) to evaluate patients' cognitive functions

  3 to 24 hours postoperative period

Secondary Outcomes (3)

• mean arterial pressure

  Duration of surgery

• heart rate

  Duration of surgery

• bispectral index

  Duration of surgery

Study Arms (2)

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

Group Sevoflurane

anesthesia was maintained with inhalation (sevoflurane concentration of 1-2% in 50-50% O2-air mixture).

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

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

Group Sevoflurane

Propofol DRUG

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

Also known as: Remifentanil

Group Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 29313909 BACKGROUND

• 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.

  PMID: 10485788 BACKGROUND

• 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.

  PMID: 19918024 BACKGROUND

• 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.

  PMID: 24263686 BACKGROUND

• 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.

  PMID: 27871574 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Sevoflurane; Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2017
• Primary Completion: June 15, 2019
• Study Completion: January 20, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

TU (1)