One-Lung VentilationNCT04760262
The Effect of Anesthesia on Cerebral Oxygenation
An observational study of One-Lung Ventilation and Thoracic Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- One-Lung Ventilation, Thoracic Surgery, Postoperative Cognitive Complications
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who would undergo thoracic surgery with one-lung ventilation (OLV)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Sevoflurane, Propofol
- Keywords
- One-lung ventilation, cerebral oxygenation, postoperative cognitive dysfunction, sevoflurane, propofol
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
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
PropofolDrug
Also called Remifentanil
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
| Study group | Role | What they receive |
|---|---|---|
| Group Propofol | anesthesia was maintained with TIVA (intravenous 125-250 µg/kg/min propofol + 0.1-0.25 µg/kg/min remifentanil infusion) Receives: Drug: Propofol | |
| Group Sevoflurane | anesthesia was maintained with inhalation (sevoflurane concentration of 1-2% in 50-50% O2-air mixture). Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Infrared Spectroscopy
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Measured: Duration of surgery
Mini mental state examination (MMSE)
Mini mental state examination (MMSE) to evaluate patients' cognitive functions
Measured: 3 to 24 hours postoperative period
Secondary outcomes (3)
mean arterial pressure
The effect of anesthetics on mean arterial pressure
Measured: Duration of surgery
heart rate
The effect of anesthetics on heart rate
Measured: Duration of surgery
bispectral index
The effects of sevoflurane and desflurane on bispectral index
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2017
- Primary completion15 Jun 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760262
- Sponsor's protocol ID
- 2013/21
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29313909Nakayama 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.
PubMed 10485788Kazan 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.
PubMed 19918024Mahal I, Davie SN, Grocott HP. Cerebral oximetry and thoracic surgery. Curr Opin Anaesthesiol. 2014 Feb;27(1):21-7. doi: 10.1097/ACO.0000000000000027.
PubMed 24263686Aguirre 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.
PubMed 27871574
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Anesthesia Techniques on Cerebral Oxygenation in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04760262
- Acronym / sponsor ID
- 2013/21
- Keywords
- One-lung ventilation, cerebral oxygenation, postoperative cognitive dysfunction, sevoflurane, propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Propofol | – | Drug: Propofolanesthesia was maintained with TIVA (intravenous 125-250 µg/kg/min propofol + 0.1-0.25 µg/kg/min remifentanil infusion) |
| Group Sevoflurane | – | Drug: Sevofluraneanesthesia was maintained with inhalation (sevoflurane concentration of 1-2% in 50-50% O2-air mixture). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who would undergo thoracic surgery with one-lung ventilation (OLV)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSevoflurane %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 | Drug | Group Sevoflurane |
| PropofolAlso: RemifentanilBIS 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 | Drug | Group Propofol |
Primary outcome
Near Infrared Spectroscopy
Time frame: Duration of surgery
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Mini mental state examination (MMSE)
Time frame: 3 to 24 hours postoperative period
Mini mental state examination (MMSE) to evaluate patients' cognitive functions
3 secondary outcomes
mean arterial pressure
Time frame: Duration of surgery
heart rate
Time frame: Duration of surgery
bispectral index
Time frame: Duration of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 29313909Hood R, Budd A, Sorond FA, Hogue CW. Peri-operative neurological complications. Anaesthesia. 2018 Jan;73 Suppl 1:67-75. doi: 10.1111/anae.14142.
- Background: PubMed 10485788Nakayama 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.
- Background: PubMed 19918024Kazan 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.
- Background: PubMed 24263686Mahal I, Davie SN, Grocott HP. Cerebral oximetry and thoracic surgery. Curr Opin Anaesthesiol. 2014 Feb;27(1):21-7. doi: 10.1097/ACO.0000000000000027.
- Background: PubMed 27871574Aguirre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One-Lung Ventilation and Thoracic Surgery, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Infrared Spectroscopy (time frame: Duration of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760262, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.