Postoperative DeliriumNCT07399184
Effect of Perioperative IV Ibuprofen on Cerebral Oxygenation and Postoperative Cognition During One-Lung Ventilation
A study testing ibuprofen in people with Postoperative Delirium and Cerebral Oxygen Saturation, run by Ondokuz Mayıs University.
Trial summary
This study compares the effects of ibuprofen administered during surgery and within the first 24 hours after surgery, versus no ibuprofen, on cerebral oxygenation, postoperative changes in consciousness (postoperative delirium and cognitive dysfunction), length of stay in the intensive care unit, and the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Delirium, Cerebral Oxygen Saturation, Postoperative Cognitive Dysfunction (POCD)
- What is being tested?
- ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 1 Sep 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
- Patients scheduled for lobectomy or segmentectomy via Video-Assisted Thoracic Surgery (VATS ) with one-lung ventilation
- New York Heart Association (NYHA) class I-II
- Patients who have been informed about the study and have provided written informed consent will be included.
Who cannot join
- Patients younger than 18 years or older than 75 years
- History of alcohol or substance abuse
- Patients with chronic NSAID use and/or NSAID use within the last 30 days, or NSAID allergy
- Allergy to other drugs used in the study (e.g., bupivacaine)
- ASA Physical Status IV-V
- Severe hearing, visual, or speech impairment
Show all 18Show fewer
- Dementia, Alzheimer's disease, or psychiatric disorders (psychosis, bipolar disorder, schizophrenia)
- History of previous head trauma
- Chronic liver disease
- Pregnancy
- History of cerebrovascular disease
- Moderate-to-severe chronic obstructive pulmonary disease (COPD) (predicted FEV₁ <50%)
- GFR <60 mL/min/1.73 m²
- Patients who do not provide written informed consent
- Conditions that may cause inaccurate cerebral oximetry readings (subdural and/or extracranial hematoma, intracranial arteriovenous shunts, hyperbilirubinemia)
- Patients undergoing emergency surgery
- Patients in whom surgery is initiated as thoracotomy or converted to thoracotomy
- Patients unable to complete the preoperative MMSE (total score ≤24) will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Ibuprofen on Cerebral Oxygenation, Postoperative Cognitive Dysfunction, and Delirium in One-Lung Ventilation
This study compares the effects of ibuprofen administered during surgery and within the first 24 hours after surgery, versus no ibuprofen, on cerebral oxygenation, postoperative changes in consciousness (postoperative delirium and cognitive dysfunction), length of stay in the intensive care unit, and the incidence of postoperative pain, nausea, vomiting, and pruritus in patients undergoing lung lobectomy or segmentectomy using a closed (video-assisted) method (VATS - video-assisted thoracoscopic surgery), in whom one-lung ventilation is applied.
The aim of this study is to evaluate the effects of ibuprofen on cerebral oxygenation, postoperative cognitive changes, and delirium in patients undergoing one-lung ventilation.
Read the detailed description
During one-lung ventilation (OLV) in thoracic surgery, cerebral oxygenation may decrease due to hypoxia, and this condition can be evaluated noninvasively using near-infrared spectroscopy (NIRS) . The ability of near-infrared light to penetrate tissues and be absorbed by oxyhemoglobin and deoxyhemoglobin forms the basic principle of measuring regional cerebral oxygen saturation. With this method, the balance between oxygen supply and demand in cerebral tissue can be continuously and dynamically assessed in real time. During measurements, it is assumed that the blood volume within the venous, capillary, and arterial compartments of the brain remains constant. Therefore, cerebral oximeters provide an average value reflecting oxygenation across these compartments. Low regional cerebral oxygen saturation values have been associated with cerebral hypoxia and/or ischemia.
Cerebral hypoxia is a well-known risk factor for postoperative delirium (POD) . While anesthesia has traditionally been considered the primary cause of postoperative delirium, animal studies suggest that surgery-induced inflammation may be an important contributor to neurological disorders associated with postoperative delirium. The peripheral inflammatory response affects the brain and contributes to the pathogenesis of postoperative delirium. Cytokines, particularly IL-1β, TNF-α, and IL-6, are believed to interact with the brain . The mechanisms by which peripheral cytokines reach the brain are thought to involve the blood-brain barrier or the circumventricular regions. These peripheral cytokines trigger microglia-derived cytokine synthesis, leading to a cycle of neuroinflammation. A recent meta-analysis of human observational studies has shown that both peripheral and cerebrospinal fluid (CSF) inflammatory markers, such as CRP and IL-6, are associated with postoperative delirium and postoperative cognitive dysfunction . Postoperative delirium occurs at a rate of 10-20% and prolongs hospital stay by 2-3 days and intensive care unit stay by approximately 2 days .
Due to surgery-induced systemic inflammatory responses, patients may also experience postoperative cognitive dysfunction (POCD). POCD is usually observed in the immediate postoperative period and manifests as a transient cognitive impairment. This condition may range from fatigue, social withdrawal, and decreased concentration to severe cognitive dysfunction. POCD may also lead to fluctuating levels of consciousness and disturbances in the sleep-wake cycle.
The incidence of POCD is highest among elderly patients. It has been observed in up to 40% of patients aged 60 years and older who undergo surgery. Although postoperative cognitive fluctuations are often not considered alarming, POCD is thought to predict the future onset of dementia and may contribute to chronic neurodegeneration with repeated surgical procedures.
Increases in pro-inflammatory cytokines during surgery trigger short-term cognitive impairment. Additionally, evidence from animal studies suggests that TNF-α-mediated dysfunction of the blood-brain barrier and migration of leukocytes into the hippocampus may lead to memory impairment. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used as a component of multimodal postoperative analgesia, and it has been suggested that these agents may prevent postoperative delirium by directly alleviating neuroinflammation. The primary mechanism of action of NSAIDs is the inhibition of the cyclooxygenase (COX) enzyme responsible for prostaglandin synthesis. The constitutive isoform, COX-1, plays a role in intercellular signaling and tissue homeostasis, whereas COX-2, which is induced in inflammatory cells, is responsible for the production of prostanoids involved in inflammation. Ibuprofen exerts its effects by inhibiting both COX-1 and COX-2. Inhibition of COX-1 may be responsible for undesirable gastrointestinal side effects ; however, inhibition of COX-2 provides ibuprofen with its analgesic, antipyretic, and anti-inflammatory properties. In a study conducted by Huang et al. in mice, perioperative use of ibuprofen was shown to improve cognitive performance, reduce systemic inflammation, and decrease glial activation . In clinical settings, preoperative administration of intravenous ibuprofen has been shown to improve postoperative cognitive function in association with reduced levels of cytokines, cortisol, and catecholamines. Additionally, another study demonstrated that the use of the NSAID flurbiprofen increased PaO₂ levels .
However, no studies have investigated the effects of ibuprofen on PaO₂, cerebral oxygenation, postoperative delirium, or postoperative cognitive dysfunction in patients undergoing one-lung ventilation.The aim of this study is to investigate the effects of administered intravenous ibuprofen on intraoperative cerebral oxygenation and subsequent postoperative cognitive function changes in patients undergoing lobectomy or segmentectomy via VATS with one-lung ventilation.
- Conditions
- Postoperative Delirium, Cerebral Oxygen Saturation, Postoperative Cognitive Dysfunction (POCD)
- Being tested
- ibuprofen
- Keywords
- cerebral oxygenation, near infrared spectroscopy, thoracic anesthesia, postoperative delirium, one lung ventilation, ibuprofen
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
Also called IV ibuprofen
In the study, patients in Group B will receive a single intraoperative dose of 400 mg IV ibuprofen, followed by postoperative administration of 400 mg IV ibuprofen three times daily for 24 hours. We hypothesize that, by benefiting from the anti-inflammatory effects of ibuprofen, intraoperative cerebral oxygenation will be preserved, thereby reducing the incidence of postoperative delirium and cognitive dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| IBUPROFEN (GROUP B) | Experimental | In the study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg intravenous ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative intravenous ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C. Receives: Drug: ibuprofen |
| CONTROL (GROUP C) | No intervention | In this study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg IV ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative IV ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right and left intraoperative cerebral oxygenation values (rScO₂)
The primary outcome of this study is the preoperative and intraoperative right and left regional cerebral oxygenation values. Cerebral oxygenation is measured using near-infrared spectroscopy (NIRS). The ability of near-infrared light to penetrate biological tissues and to be absorbed by oxyhemoglobin and deoxyhemoglobin constitutes the basic principle of regional cerebral oxygen saturation measurement. Using this method, the balance between oxygen supply and demand in cerebral tissue can be continuously evaluated in real time. During measurements, it is assumed that the blood volume within the venous, capillary, and arterial compartments of the brain remains constant. Therefore, cerebral oximeters provide an average value reflecting the oxygenation of these compartments. Low regional cerebral oxygen saturation values have been associated with cerebral hypoxia and/or ischemia.
Measured: preoperative and intraoperative
Secondary outcomes (4)
Postoperative cognitive dysfunction (MMSE score)
Cognitive functions in the preoperative and postoperative periods will be assessed using the Mini-Mental State Examination (MMSE) for patients with at least 5 years of education, and the MMSE for uneducated individuals for those with less than 5 years of education. Patients unable to complete the test (total score ≤24) will be excluded from the study.
Measured: until the end of postoperative day 2 and preoperative day
Postoperative delirium score (NU-DESC)
NU-DESC is a delirium screening tool. A total score of 2 or higher will be considered clinically significant for delirium.
Measured: until the end of postoperative day 2
Postoperative Resting and activity NRS score (Numeric Rating Scale)
Patients' pain will be assessed using the Resting and activity NRS (Numeric Rating Scale), scored from 0 to 10. Rescue analgesia will be administered if the score is 4 or higher.
Measured: until the end of postoperative day 1
Postoperative nausea and vomiting status
Nausea and vomiting will be assessed using the Verbal Descriptive Scale (VDS), with scores ranging from 0 to 4. Accordingly, patients with a score of 3 or higher will receive IV ondansetron at a dose of 0.05 mg/kg.
Measured: until the end of postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is conducted using a parallel-group interventional study model. Eligible participants are randomly assigned in a 1:1 ratio to one of two groups: the ibuprofen intervention group or the control group. Randomization is performed using a computer-generated allocation sequence and implemented via sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The intervention is applied perioperatively, and participants remain in their assigned group throughout the study with no crossover between groups. Outcomes are assessed and compared between groups in parallel over the defined intraoperative and postoperative follow-up period. The study is designed as prospective, single-center, randomized, controlled, and single-blind, consistent with a parallel assignment model.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Bengi SENER, Ondokuz Mayıs University
- Investigators
- Canan ASAR SAHIN, Study director, Ondokuz Mayıs University Faculty of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399184
- Sponsor's protocol ID
- IBU2025
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen L, Chen JQ, Yang XL, Hu JC, Gao W, Chai XQ, Wang D. Corrigendum: Flurbiprofen used in one-lung ventilation improves intraoperative regional cerebral oxygen saturation and reduces the incidence of postoperative delirium. Front Psychiatry. 2023 Jun 6;14:1228369. doi: 10.3389/fpsyt.2023.1228369. eCollection 2023.
PubMed 37346900Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
PubMed 22311364Hayashi K, Yamada Y, Ishihara T, Tanabe K, Iida H. Comparison of regional cerebral oxygen saturation during one-lung ventilation under desflurane or propofol anesthesia: A randomized trial. Medicine (Baltimore). 2022 Oct 14;101(41):e30030. doi: 10.1097/MD.0000000000030030.
PubMed 36254073Liu Z, Jin Y, Wang L, Huang Z. The Effect of Ciprofol on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery for Lung Cancer: A Prospective, Randomized, Controlled Trial. Drug Des Devel Ther. 2024 Feb 5;18:325-339. doi: 10.2147/DDDT.S441950. eCollection 2024.
PubMed 38344256
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ibuprofen on Cerebral Oxygenation, Postoperative Cognitive Dysfunction, and Delirium in One-Lung Ventilation
- ClinicalTrials.gov ID
- NCT07399184
- Acronym / sponsor ID
- IBU2025
- Conditions
- Postoperative Delirium, Cerebral Oxygen Saturation, Postoperative Cognitive Dysfunction (POCD)
- Keywords
- cerebral oxygenation, near infrared spectroscopy, thoracic anesthesia, postoperative delirium, one lung ventilation, ibuprofen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Feb 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.
This study compares the effects of ibuprofen administered during surgery and within the first 24 hours after surgery, versus no ibuprofen, on cerebral oxygenation, postoperative changes in consciousness (postoperative delirium and cognitive dysfunction), length of stay in the intensive care unit, and the incidence of postoperative pain, nausea, vomiting, and pruritus in patients undergoing lung lobectomy or segmentectomy using a closed (video-assisted) method (VATS - video-assisted thoracoscopic surgery), in whom one-lung ventilation is applied.
The aim of this study is to evaluate the effects of ibuprofen on cerebral oxygenation, postoperative cognitive changes, and delirium in patients undergoing one-lung ventilation.
Detailed description
During one-lung ventilation (OLV) in thoracic surgery, cerebral oxygenation may decrease due to hypoxia, and this condition can be evaluated noninvasively using near-infrared spectroscopy (NIRS) . The ability of near-infrared light to penetrate tissues and be absorbed by oxyhemoglobin and deoxyhemoglobin forms the basic principle of measuring regional cerebral oxygen saturation. With this method, the balance between oxygen supply and demand in cerebral tissue can be continuously and dynamically assessed in real time. During measurements, it is assumed that the blood volume within the venous, capillary, and arterial compartments of the brain remains constant. Therefore, cerebral oximeters provide an average value reflecting oxygenation across these compartments. Low regional cerebral oxygen saturation values have been associated with cerebral hypoxia and/or ischemia.
Cerebral hypoxia is a well-known risk factor for postoperative delirium (POD) . While anesthesia has traditionally been considered the primary cause of postoperative delirium, animal studies suggest that surgery-induced inflammation may be an important contributor to neurological disorders associated with postoperative delirium. The peripheral inflammatory response affects the brain and contributes to the pathogenesis of postoperative delirium. Cytokines, particularly IL-1β, TNF-α, and IL-6, are believed to interact with the brain . The mechanisms by which peripheral cytokines reach the brain are thought to involve the blood-brain barrier or the circumventricular regions. These peripheral cytokines trigger microglia-derived cytokine synthesis, leading to a cycle of neuroinflammation. A recent meta-analysis of human observational studies has shown that both peripheral and cerebrospinal fluid (CSF) inflammatory markers, such as CRP and IL-6, are associated with postoperative delirium and postoperative cognitive dysfunction . Postoperative delirium occurs at a rate of 10-20% and prolongs hospital stay by 2-3 days and intensive care unit stay by approximately 2 days .
Due to surgery-induced systemic inflammatory responses, patients may also experience postoperative cognitive dysfunction (POCD). POCD is usually observed in the immediate postoperative period and manifests as a transient cognitive impairment. This condition may range from fatigue, social withdrawal, and decreased concentration to severe cognitive dysfunction. POCD may also lead to fluctuating levels of consciousness and disturbances in the sleep-wake cycle.
The incidence of POCD is highest among elderly patients. It has been observed in up to 40% of patients aged 60 years and older who undergo surgery. Although postoperative cognitive fluctuations are often not considered alarming, POCD is thought to predict the future onset of dementia and may contribute to chronic neurodegeneration with repeated surgical procedures.
Increases in pro-inflammatory cytokines during surgery trigger short-term cognitive impairment. Additionally, evidence from animal studies suggests that TNF-α-mediated dysfunction of the blood-brain barrier and migration of leukocytes into the hippocampus may lead to memory impairment. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used as a component of multimodal postoperative analgesia, and it has been suggested that these agents may prevent postoperative delirium by directly alleviating neuroinflammation. The primary mechanism of action of NSAIDs is the inhibition of the cyclooxygenase (COX) enzyme responsible for prostaglandin synthesis. The constitutive isoform, COX-1, plays a role in intercellular signaling and tissue homeostasis, whereas COX-2, which is induced in inflammatory cells, is responsible for the production of prostanoids involved in inflammation. Ibuprofen exerts its effects by inhibiting both COX-1 and COX-2. Inhibition of COX-1 may be responsible for undesirable gastrointestinal side effects ; however, inhibition of COX-2 provides ibuprofen with its analgesic, antipyretic, and anti-inflammatory properties. In a study conducted by Huang et al. in mice, perioperative use of ibuprofen was shown to improve cognitive performance, reduce systemic inflammation, and decrease glial activation . In clinical settings, preoperative administration of intravenous ibuprofen has been shown to improve postoperative cognitive function in association with reduced levels of cytokines, cortisol, and catecholamines. Additionally, another study demonstrated that the use of the NSAID flurbiprofen increased PaO₂ levels .
However, no studies have investigated the effects of ibuprofen on PaO₂, cerebral oxygenation, postoperative delirium, or postoperative cognitive dysfunction in patients undergoing one-lung ventilation.The aim of this study is to investigate the effects of administered intravenous ibuprofen on intraoperative cerebral oxygenation and subsequent postoperative cognitive function changes in patients undergoing lobectomy or segmentectomy via VATS with one-lung ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is conducted using a parallel-group interventional study model. Eligible participants are randomly assigned in a 1:1 ratio to one of two groups: the ibuprofen intervention group or the control group. Randomization is performed using a computer-generated allocation sequence and implemented via sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The intervention is applied perioperatively, and participants remain in their assigned group throughout the study with no crossover between groups. Outcomes are assessed and compared between groups in parallel over the defined intraoperative and postoperative follow-up period. The study is designed as prospective, single-center, randomized, controlled, and single-blind, consistent with a parallel assignment model.
| Arm | Type | Receives |
|---|---|---|
| IBUPROFEN (GROUP B) | Experimental | Drug: ibuprofenIn the study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg intravenous ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative intravenous ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C. |
| CONTROL (GROUP C) | No intervention | –In this study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg IV ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative IV ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-75 years
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
- Patients scheduled for lobectomy or segmentectomy via Video-Assisted Thoracic Surgery (VATS ) with one-lung ventilation
- New York Heart Association (NYHA) class I-II
- Patients who have been informed about the study and have provided written informed consent will be included.
Key exclusion criteria (18 listed)
- Patients younger than 18 years or older than 75 years
- History of alcohol or substance abuse
- Patients with chronic NSAID use and/or NSAID use within the last 30 days, or NSAID allergy
- Allergy to other drugs used in the study (e.g., bupivacaine)
- ASA Physical Status IV-V
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 |
|---|---|---|
| ibuprofenAlso: IV ibuprofenIn the study, patients in Group B will receive a single intraoperative dose of 400 mg IV ibuprofen, followed by postoperative administration of 400 mg IV ibuprofen three times daily for 24 hours. We hypothesize that, by benefiting from the anti-inflammatory effects of ibuprofen, intraoperative cerebral oxygenation will be preserved, thereby reducing the incidence of postoperative delirium and cognitive dysfunction. | Drug | IBUPROFEN (GROUP B) |
Primary outcome
Right and left intraoperative cerebral oxygenation values (rScO₂)
Time frame: preoperative and intraoperative
The primary outcome of this study is the preoperative and intraoperative right and left regional cerebral oxygenation values. Cerebral oxygenation is measured using near-infrared spectroscopy (NIRS). The ability of near-infrared light to penetrate biological tissues and to be absorbed by oxyhemoglobin and deoxyhemoglobin constitutes the basic principle of regional cerebral oxygen saturation measurement. Using this method, the balance between oxygen supply and demand in cerebral tissue can be continuously evaluated in real time. During measurements, it is assumed that the blood volume within the venous, capillary, and arterial compartments of the brain remains constant. Therefore, cerebral oximeters provide an average value reflecting the oxygenation of these compartments. Low regional cerebral oxygen saturation values have been associated with cerebral hypoxia and/or ischemia.
4 secondary outcomes
Postoperative cognitive dysfunction (MMSE score)
Time frame: until the end of postoperative day 2 and preoperative day
Postoperative delirium score (NU-DESC)
Time frame: until the end of postoperative day 2
Postoperative Resting and activity NRS score (Numeric Rating Scale)
Time frame: until the end of postoperative day 1
Postoperative nausea and vomiting status
Time frame: until the end of postoperative day 1
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 10 Feb 2026.
- Background: PubMed 37346900Shen L, Chen JQ, Yang XL, Hu JC, Gao W, Chai XQ, Wang D. Corrigendum: Flurbiprofen used in one-lung ventilation improves intraoperative regional cerebral oxygen saturation and reduces the incidence of postoperative delirium. Front Psychiatry. 2023 Jun 6;14:1228369. doi: 10.3389/fpsyt.2023.1228369. eCollection 2023.
- Background: PubMed 22311364Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
- Background: PubMed 36254073Hayashi K, Yamada Y, Ishihara T, Tanabe K, Iida H. Comparison of regional cerebral oxygen saturation during one-lung ventilation under desflurane or propofol anesthesia: A randomized trial. Medicine (Baltimore). 2022 Oct 14;101(41):e30030. doi: 10.1097/MD.0000000000030030.
- Background: PubMed 38344256Liu Z, Jin Y, Wang L, Huang Z. The Effect of Ciprofol on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery for Lung Cancer: A Prospective, Randomized, Controlled Trial. Drug Des Devel Ther. 2024 Feb 5;18:325-339. doi: 10.2147/DDDT.S441950. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
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.
Canan ASAR SAHIN study director
Ondokuz Mayıs University Faculty of Medicine Department of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing ibuprofen in people with Postoperative Delirium and Cerebral Oxygen Saturation, run by Ondokuz Mayıs University.
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 18 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elif Bengi SENER (+90 (532) 341 67 11, bengimd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right and left intraoperative cerebral oxygenation values (rScO₂) (time frame: preoperative and intraoperative). 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 NCT07399184, which also lists 4 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 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.