Thoracic AnesthesiaNCT07339124
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
An observational study of Thoracic Anesthesia and Geriatric Anesthesia, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
One lung ventilation (OLV) is commonly used in thoracic surgery. Although the lack of ventilation of the lung in the surgical area (independent lung) during OLV redirects pulmonary blood flow to the dependent lung, shunt development is inevitable, and consequently, hypoxia is a frequently encountered condition. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Thoracic Anesthesia, Geriatric Anesthesia, One Lung Ventillation (OLV)
- What is being tested?
- Cognitive Remediation and Pain Medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will be conducted in accordance with the Helsinki Declaration and will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital after obtaining ethical committee approval. The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for single-lung ventilation (TAV) with standard anesthesia monitoring
Who may be able to join
- Patients aged 65 and over with a high school diploma or higher education
- Patients undergoing lung resection via thoracotomy (wedge resection, lingulectomy, segmentectomy, lobectomy, pneumonectomy)
- American Society of Anesthesiologists (ASA) score I-II-III,
- Body mass index (BMI) between 18-40 kg/m2,
- Patients undergoing surgery under general anesthesia will be included in the study.
Who cannot join
- Patients under 65 years of age, patients over 65 who are illiterate,
- Who have completed primary or secondary school,
- Patients with pre-existing cognitive impairment confirmed by preoperative Mini Mental State Examination (MMSE),
- Patients with a history of previously diagnosed mental illness, cerebrovascular disease, senile dementia, stroke,
- Patients using continuous anti-inflammatory/analgesic medications,
- Patients with preoperative chronic pain,
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- Severe cardiovascular disease,
- Diagnosed neurological and psychiatric diseases,
- Patients allergic to the anesthetic and analgesic drugs to be administered,
- Patients with severe renal failure, gastrointestinal ulceration or severe asthma that prevents the administration of standard analgesia protocols,
- Patients undergoing surgery other than lung resection,
- Patients undergoing surgery with TIVA (total intravenous anesthesia) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Training and Research Hospital
Ankara
About this study
Official title: The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients Undergoing Single Lung Ventilation; Prospective Observational Study
One lung ventilation (OLV) is commonly used in thoracic surgery. Although the lack of ventilation of the lung in the surgical area (independent lung) during OLV redirects pulmonary blood flow to the dependent lung, shunt development is inevitable, and consequently, hypoxia is a frequently encountered condition. Therefore, one of the most important aspects that clinicians pay attention to during OLV is cerebral oxygen saturation in addition to peripheral oxygenation monitoring.
Studies have shown a correlation between decreased cerebral oxygen saturation and postoperative cognitive dysfunction (POCD). Patients undergoing OLV are also at risk of cerebral desaturation due to this non-physiological ventilation.
Read more
Patients undergoing OLV are at risk of cerebral oxygen desaturation. Therefore, in these patients, both cognitive dysfunction and changes in brain oxygenation can negatively affect pain-related centers, altering pain perception. Geriatric patients are particularly more affected by these negative effects. It is generally accepted by healthcare professionals specializing in pain management that the application of pain management should differ for elderly patients compared to younger patients. Analgesic dose adjustment should be done more carefully in geriatric patients. Increased sensitivity to opioids due to hypoxia can cause respiratory depression and increased analgesic effects. To avoid these, opioid dose adjustment is necessary in these patients. In conclusion, cerebral oxygen saturation measurement can be an effective method to detect cerebral oxygen desaturation, especially in the geriatric patient group. In this way, the effect of hypoxia caused by OLV on cerebral oxygen saturation can be detected early, and POCD can be limited. We believe that this situation can also contribute to effective postoperative pain management. This study aimed to investigate the effect of intraoperative brain oxygenation on cognitive function and postoperative pain in geriatric patients who underwent OLV.
MATERİAL AND METHODS This study will be conducted in accordance with the Helsinki Declaration and will take place at Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital . The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for OLV with standard anesthesia monitoring. These patients, undergoing thoracic surgery via thoracotomy and who agree to participate in this study and sign an informed consent form, will be prospectively enrolled. A total of 30 patients will be included in our study. Preoperatively, patients will undergo standard monitoring including non-invasive arterial blood pressure, electrocardiography, and peripheral oxygen saturation (SpO2). Cerebral oxygenation of patients who have signed an informed consent form the day before will be recorded throughout the surgical procedure using probes placed on the forehead before the induction of anesthetic drugs.
The standard anesthesia and analgesia protocol that we routinely apply to patients will be applied throughout the surgery. Routine preoperative blood tests, age, height, weight, Body Mass Index (BMI), gender, diagnosis, preoperative comorbidities (hypertension, diabetes, coronary artery disease, chronic obstructive pulmonary disease, etc.), previous surgeries (any surgical procedure performed under general anesthesia before this study), American Society of Anesthesiologists ( ASA) score, and duration of surgery will be recorded for each patient. Hemodynamic data (systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), pulse, SpO2, and cerebral oxygen saturation will be recorded before anesthesia induction, after induction, and at 5, 10, 20, 30, and 60 minutes after the start of OLV. These hemodynamic data will also be recorded at the end OLV and at the end of the operation. OLV duration, anesthesia duration, surgery duration, amount of fluid administered, urine output, and whether blood replacement was performed will be recorded. Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively. Analgesic medications administered during the 24-hour postoperative period will also be recorded. VAS evaluation will be performed on a 100 mm scale, where 0: no pain and 100: maximum pain, indicating the patient's pain level. During this process, any possible side effects that may develop due to analgesic treatment will be recorded.
The Mini Mental Test (MMT) form will be completed by patients one day before surgery, 48 hours postoperatively, on the 7th day postoperatively. MMT consists of eleven items grouped under five main headings: Orientation, recording memory, attention and calculation, recall, and language, and is evaluated out of a total score of 30.
Read the detailed description
H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on cognitive function.
H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on cognitive function.
H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on postoperative pain.
H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on postoperative pain.
- Conditions
- Thoracic Anesthesia, Geriatric Anesthesia, One Lung Ventillation (OLV), POCD - Postoperative Cognitive Dysfunction, Postoperative Pain Management
- Being tested
- Cognitive Remediation, Pain Medicine
- Keywords
- thoracic anesthesia, geriatric patients, cognitive function, one lung ventilation, cerebral oxygenation, postoperative pain
- Medical subject headings
- Postoperative Cognitive Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationOther
One day before the operation, postoperative The Mini Mental Test (MMT) form will be completed by patients at 48 hours and on the 7th postoperative day
Pain MedicineOther
Pain levels of patients at 1, 2, 4, 8, 16, and 24 hours after thoracotomy will be evaluated using the Visual Analog Scale (VAS)
| Study group | Role | What they receive |
|---|---|---|
| Patients over 65 years of age who will undergo single-lung ventilation with thoracotomy. | The duration of single-lung ventilation and cerebral oxygenation values administered to patients during the intraoperative period will be recorded. The effects of these values on postoperative cognitive function and pain will be analyzed using statistical methods. Receives: Other: Cognitive Remediation; Other: Pain Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental Test Measurements
Measured: 24 hours before surgery, 48 hours after surgery, and on the 7th postoperative day, or 7 days before discharge, or immediately before discharge.
Mini Mental Test Measurements
Measured: 24 hours before surgery, 48 hours after surgery, and on the 7th postoperative day, or immediately before discharge if the discharge date is less than 7 days.
Secondary outcomes (1)
Visual Analog Scale (VAS) scores
During VAS evaluation, the patient will be asked to indicate the location of their pain intensity on a 100 mm scale (0: no pain, 100: maximum pain),
Measured: Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Jan 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Baldemir, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Fatma Öztürk Yalçın, Principal investigator, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339124
- Sponsor's protocol ID
- 2024-BÇEK/426
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients Undergoing Single Lung Ventilation; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07339124
- Acronym / sponsor ID
- 2024-BÇEK/426
- Conditions
- Thoracic Anesthesia, Geriatric Anesthesia, One Lung Ventillation (OLV), POCD - Postoperative Cognitive Dysfunction, Postoperative Pain Management
- Keywords
- thoracic anesthesia, geriatric patients, cognitive function, one lung ventilation, cerebral oxygenation, postoperative pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 14 Jan 2026 (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) is commonly used in thoracic surgery. Although the lack of ventilation of the lung in the surgical area (independent lung) during OLV redirects pulmonary blood flow to the dependent lung, shunt development is inevitable, and consequently, hypoxia is a frequently encountered condition. Therefore, one of the most important aspects that clinicians pay attention to during OLV is cerebral oxygen saturation in addition to peripheral oxygenation monitoring.
Studies have shown a correlation between decreased cerebral oxygen saturation and postoperative cognitive dysfunction (POCD). Patients undergoing OLV are also at risk of cerebral desaturation due to this non-physiological ventilation.
Patients undergoing OLV are at risk of cerebral oxygen desaturation. Therefore, in these patients, both cognitive dysfunction and changes in brain oxygenation can negatively affect pain-related centers, altering pain perception. Geriatric patients are particularly more affected by these negative effects. It is generally accepted by healthcare professionals specializing in pain management that the application of pain management should differ for elderly patients compared to younger patients. Analgesic dose adjustment should be done more carefully in geriatric patients. Increased sensitivity to opioids due to hypoxia can cause respiratory depression and increased analgesic effects. To avoid these, opioid dose adjustment is necessary in these patients. In conclusion, cerebral oxygen saturation measurement can be an effective method to detect cerebral oxygen desaturation, especially in the geriatric patient group. In this way, the effect of hypoxia caused by OLV on cerebral oxygen saturation can be detected early, and POCD can be limited. We believe that this situation can also contribute to effective postoperative pain management. This study aimed to investigate the effect of intraoperative brain oxygenation on cognitive function and postoperative pain in geriatric patients who underwent OLV.
MATERİAL AND METHODS This study will be conducted in accordance with the Helsinki Declaration and will take place at Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital . The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for OLV with standard anesthesia monitoring. These patients, undergoing thoracic surgery via thoracotomy and who agree to participate in this study and sign an informed consent form, will be prospectively enrolled. A total of 30 patients will be included in our study. Preoperatively, patients will undergo standard monitoring including non-invasive arterial blood pressure, electrocardiography, and peripheral oxygen saturation (SpO2). Cerebral oxygenation of patients who have signed an informed consent form the day before will be recorded throughout the surgical procedure using probes placed on the forehead before the induction of anesthetic drugs.
The standard anesthesia and analgesia protocol that we routinely apply to patients will be applied throughout the surgery. Routine preoperative blood tests, age, height, weight, Body Mass Index (BMI), gender, diagnosis, preoperative comorbidities (hypertension, diabetes, coronary artery disease, chronic obstructive pulmonary disease, etc.), previous surgeries (any surgical procedure performed under general anesthesia before this study), American Society of Anesthesiologists ( ASA) score, and duration of surgery will be recorded for each patient. Hemodynamic data (systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), pulse, SpO2, and cerebral oxygen saturation will be recorded before anesthesia induction, after induction, and at 5, 10, 20, 30, and 60 minutes after the start of OLV. These hemodynamic data will also be recorded at the end OLV and at the end of the operation. OLV duration, anesthesia duration, surgery duration, amount of fluid administered, urine output, and whether blood replacement was performed will be recorded. Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively. Analgesic medications administered during the 24-hour postoperative period will also be recorded. VAS evaluation will be performed on a 100 mm scale, where 0: no pain and 100: maximum pain, indicating the patient's pain level. During this process, any possible side effects that may develop due to analgesic treatment will be recorded.
The Mini Mental Test (MMT) form will be completed by patients one day before surgery, 48 hours postoperatively, on the 7th day postoperatively. MMT consists of eleven items grouped under five main headings: Orientation, recording memory, attention and calculation, recall, and language, and is evaluated out of a total score of 30.
Detailed description
H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on cognitive function.
H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on cognitive function.
H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on postoperative pain.
H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients over 65 years of age who will undergo single-lung ventilation with thoracotomy. | – | Other: Cognitive Remediation, Other: Pain MedicineThe duration of single-lung ventilation and cerebral oxygenation values administered to patients during the intraoperative period will be recorded. The effects of these values on postoperative cognitive function and pain will be analyzed using statistical methods. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will be conducted in accordance with the Helsinki Declaration and will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital after obtaining ethical committee approval. The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for single-lung ventilation (TAV) with standard anesthesia monitoring
Key inclusion criteria (5 listed)
- Patients aged 65 and over with a high school diploma or higher education
- Patients undergoing lung resection via thoracotomy (wedge resection, lingulectomy, segmentectomy, lobectomy, pneumonectomy)
- American Society of Anesthesiologists (ASA) score I-II-III,
- Body mass index (BMI) between 18-40 kg/m2,
- Patients undergoing surgery under general anesthesia will be included in the study.
Key exclusion criteria (12 listed)
- Patients under 65 years of age, patients over 65 who are illiterate,
- Who have completed primary or secondary school,
- Patients with pre-existing cognitive impairment confirmed by preoperative Mini Mental State Examination (MMSE),
- Patients with a history of previously diagnosed mental illness, cerebrovascular disease, senile dementia, stroke,
- Patients using continuous anti-inflammatory/analgesic medications,
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 |
|---|---|---|
| Cognitive RemediationOne day before the operation, postoperative The Mini Mental Test (MMT) form will be completed by patients at 48 hours and on the 7th postoperative day | Other | Patients over 65 years of age who will undergo single-lung ventilation with thoracotomy. |
| Pain MedicinePain levels of patients at 1, 2, 4, 8, 16, and 24 hours after thoracotomy will be evaluated using the Visual Analog Scale (VAS) | Other | Patients over 65 years of age who will undergo single-lung ventilation with thoracotomy. |
Primary outcome
Mini Mental Test Measurements
Time frame: 24 hours before surgery, 48 hours after surgery, and on the 7th postoperative day, or 7 days before discharge, or immediately before discharge.
Mini Mental Test Measurements
Time frame: 24 hours before surgery, 48 hours after surgery, and on the 7th postoperative day, or immediately before discharge if the discharge date is less than 7 days.
1 secondary outcome
Visual Analog Scale (VAS) scores
Time frame: Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Fatma Öztürk Yalçın principal investigator
ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
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 Thoracic Anesthesia and Geriatric Anesthesia, run by Ankara Ataturk Sanatorium Training and Research Hospital 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mini Mental Test Measurements (time frame: 24 hours before surgery, 48 hours after surgery, and on the 7th postoperative day, or 7 days before discharge, or immediately before discharge.). 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?
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 3 Nov 2026.