Inguinal Hernia UnilateralPhase 4IBU-COGNCT07424001
Preemptive IV Ibuprofen for Neurocognitive Recovery and Analgesic Needs After Inguinal Hernia Surgery
A Phase 4 study testing Ibuprofen (400 mg x 4) in people with Inguinal Hernia Unilateral and Delayed Neurocognitive Recovery, run by Mehmet Çiğdem at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study is to evaluate the effects of preemptive intravenous ibuprofen administration on delayed neurocognitive recovery (dNCR), postoperative pain management, and the overall quality of recovery in geriatric patients undergoing open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 65 to 84 years, men only
- Conditions the study is for
- Inguinal Hernia Unilateral, Delayed Neurocognitive Recovery, Postoperative Pain
- What is being tested?
- Ibuprofen (400 mg x 4)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2025to 30 Jan 2026
- Phase
- Phase 4
- 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 65 to 84 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Male patients between the ages of 65 and 84.
- ASA (American Society of Anesthesiologists) physical status I - III.
- Preoperative Mini-Mental State Examination (MMSE) score of \ge24.
- Undergoing elective (non-emergency) open inguinal hernia repair using the
- Lichtenstein tension-free method with mesh.
- Literate and able to communicate sufficiently to understand Turkish cognitive tests.
Who cannot join
- Illiterate patients.
- History of active alcoholism or substance abuse.
- Neuro-psychiatric disorders such as Parkinson's, Alzheimer's, vascular dementia, advanced stroke sequelae, schizophrenia, or major depressive disorder.
- Active metastatic cancer or terminal illness.
- Known allergy to nonsteroidal anti-inflammatory drugs (especially ibuprofen), acetylsalicylic acid, or other drugs used in the study.
- Advanced COPD or uncontrolled bronchial asthma (FEV1 <50%).
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- Uncontrolled hypertension, congestive heart failure (NYHA Class IV), recent myocardial infarction, or serious arrhythmias.
- Thrombocytopenia (<50,000), coagulopathy, active peptic ulcer, or recent gastrointestinal bleeding history (within the last year).
- Advanced liver failure (Child-Pugh C) or kidney failure (creatinine >2.5 mg/dL or dialysis requirement).
- Body Mass Index (BMI) \ge35 (morbid obesity) or body weight <40 kg.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul, Kadıköy, 34710
About this study
Official title: Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery
The primary objective of this study is to evaluate the effects of preemptive intravenous ibuprofen administration on delayed neurocognitive recovery (dNCR), postoperative pain management, and the overall quality of recovery in geriatric patients undergoing open inguinal hernia repair. Elderly patients are particularly susceptible to perioperative neurocognitive dysfunction, which is often triggered by the systemic inflammatory response following surgery and anesthesia.
In this prospective, randomized, double-blind, controlled trial, 76 male patients aged 65-84 were divided into two groups. Group 1 received 800 mg of intravenous ibuprofen 30 minutes before anesthesia induction, while Group 2 received a 0.9% NaCl solution as a placebo. The study focuses on three main clinical outcomes:
Read more
- Neurocognitive Recovery: Cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA) test at baseline, and on postoperative days 1 and 7 to determine if preemptive ibuprofen can reduce the incidence of dNCR by suppressing neuroinflammation.
- Analgesic Requirement and Pain Control: The study measures postoperative pain scores (VAS) and total opioid (tramadol) consumption over the first 24 hours to evaluate the "opioid-sparing" effect of preemptive ibuprofen.
- Quality of Recovery: The overall recovery quality is assessed on the 1st postoperative day using the Quality of Recovery-15 (QoR-15) scale, which measures the patient's subjective physical and emotional well-being.
The hypothesis is that by mitigating the surgical inflammatory response, preemptive ibuprofen will protect cognitive function, significantly lower the patient's reliance on opioids, and enhance the overall quality of the postoperative recovery process.
Read the detailed description
This prospective, randomized, double-blind, placebo-controlled study was designed to investigate the effects of preemptive intravenous ibuprofen on neurocognitive recovery, pain management, and the quality of recovery in geriatric patients. The study included 76 male patients, aged 65-84 years, with an ASA physical status of I-III, scheduled for elective open inguinal hernia repair.
Study Protocol:
Patients were randomly assigned into two equal groups (n=38 each) using a sealed envelope method:
- Ibuprofen Group (Group 1): Received 800 mg of intravenous ibuprofen (diluted in 200 mL of 0.9% NaCl) administered via infusion 30 minutes before anesthesia induction.
- Control Group (Group 2): Received 200 mL of 0.9% NaCl (placebo) administered via infusion 30 minutes before anesthesia induction.
Anesthesia and Monitoring:
A standardized general anesthesia protocol was applied to all participants. Monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Additionally, the Bispectral Index (BIS) was used to monitor anesthesia depth (target: 40-60), and Near-Infrared Spectroscopy (NIRS) was utilized to monitor bilateral cerebral oxygenation.
Outcomes and Assessments:
- Neurocognitive Recovery: The Montreal Cognitive Assessment (MoCA) was used to evaluate cognitive functions at three time points: 24 hours preoperatively (baseline), on postoperative day 1 (POD1), and on postoperative day 7 (POD7). Delayed Neurocognitive Recovery (dNCR) was defined as a decrease of \ge2 points in the MoCA score compared to baseline.
- Analgesic Requirement: Postoperative pain intensity was measured using the Visual Analog Scale (VAS) at rest and during movement at the 1st, 6th, 12th, and 24th hours. Total opioid (tramadol) consumption and the need for rescue analgesia were recorded over the first 24 hours.
- Quality of Recovery: Subjective recovery quality was assessed on the first postoperative day using the Quality of Recovery-15 (QoR-15) scale, which evaluates physical and emotional well-being.
The study hypothesizes that preemptive ibuprofen administration mitigates the systemic inflammatory response triggered by surgery, thereby reducing neuroinflammation, decreasing postoperative opioid reliance, and improving the overall quality of recovery for elderly patients.
- Conditions
- Inguinal Hernia Unilateral, Delayed Neurocognitive Recovery, Postoperative Pain, Neuroinflammation, Preemptive Analgesia
- Being tested
- Ibuprofen (400 mg x 4), Placebo (NaCl 0.9 % solution)
- Keywords
- Ibuprofen, Preemptive Analgesia, Geriatric Patients, Quality of Recovery, Montreal Cognitive Assessment
- Medical subject headings
- Pain, Postoperative, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen (400 mg x 4)Drug
Also called Dorifen®
800 mg intravenous infusion, administered 30 minutes before anesthesia induction.
Placebo (NaCl 0.9 % solution)Other
200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen Group | Experimental | Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 800 mg intravenous ibuprofen before anesthesia induction. Receives: Drug: Ibuprofen (400 mg x 4) |
| Control Group | Placebo comparator | Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 200 mL 0.9% NaCl (saline) before anesthesia induction. Receives: Other: Placebo (NaCl 0.9 % solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) Score.
The MoCA is a 30-point tool used to evaluate cognitive domains such as memory, attention, and executive functions. A decline of ≥ 2 points from the preoperative baseline is defined as the occurrence of Delayed Neurocognitive Recovery (dNCR).
Measured: Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7.
Secondary outcomes (4)
Visual Analog Scale (VAS) Score.
Pain intensity measured on a scale from 0 (no pain) to 10 (unbearable pain).
Measured: Postoperative 1st, 6th, 12th, and 24th hours.
Total Postoperative Tramadol Consumption.
The cumulative amount of intravenous tramadol (in milligrams) administered for pain management over the first 24 hours after surgery.
Measured: Postoperative 24 hours.
Quality of Recovery-15 (QoR-15) Score.
A 15-item questionnaire assessing the patient's physical and emotional well-being during recovery, with scores ranging from 0 to 150 (higher scores indicate better recovery).
Measured: Postoperative Day 1.
Regional Cerebral Oxygen Saturation (rScO2).
Measured via Near-Infrared Spectroscopy (NIRS) to monitor bilateral frontal lobe oxygenation during surgery.
Measured: From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start27 Sep 2025
- Primary completion22 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Çiğdem
- Sponsor type
- University, hospital or other
- Collaborators
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Responsible party
- Sponsor-investigator, Mehmet Çiğdem, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424001
- Sponsor's protocol ID
- IMU-2025-0072
- Other IDs
- E-24931227-514.04.02-5738966
- Acronym
- IBU-COG
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected during the study will not be shared with external researchers to protect participant confidentiality and comply with the institutional ethics committee guidelines. Only aggregated data and statistical results presented in the final thesis and related publications will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT07424001
- Acronym / sponsor ID
- IBU-COG / IMU-2025-0072
- Conditions
- Inguinal Hernia Unilateral, Delayed Neurocognitive Recovery, Postoperative Pain, Neuroinflammation, Preemptive Analgesia
- Keywords
- Ibuprofen, Preemptive Analgesia, Geriatric Patients, Quality of Recovery, Montreal Cognitive Assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mehmet ÇiğdemUniversity, hospital or other
- Collaborators
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 20 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.
The primary objective of this study is to evaluate the effects of preemptive intravenous ibuprofen administration on delayed neurocognitive recovery (dNCR), postoperative pain management, and the overall quality of recovery in geriatric patients undergoing open inguinal hernia repair. Elderly patients are particularly susceptible to perioperative neurocognitive dysfunction, which is often triggered by the systemic inflammatory response following surgery and anesthesia.
In this prospective, randomized, double-blind, controlled trial, 76 male patients aged 65-84 were divided into two groups. Group 1 received 800 mg of intravenous ibuprofen 30 minutes before anesthesia induction, while Group 2 received a 0.9% NaCl solution as a placebo. The study focuses on three main clinical outcomes:
- Neurocognitive Recovery: Cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA) test at baseline, and on postoperative days 1 and 7 to determine if preemptive ibuprofen can reduce the incidence of dNCR by suppressing neuroinflammation.
- Analgesic Requirement and Pain Control: The study measures postoperative pain scores (VAS) and total opioid (tramadol) consumption over the first 24 hours to evaluate the "opioid-sparing" effect of preemptive ibuprofen.
- Quality of Recovery: The overall recovery quality is assessed on the 1st postoperative day using the Quality of Recovery-15 (QoR-15) scale, which measures the patient's subjective physical and emotional well-being.
The hypothesis is that by mitigating the surgical inflammatory response, preemptive ibuprofen will protect cognitive function, significantly lower the patient's reliance on opioids, and enhance the overall quality of the postoperative recovery process.
Detailed description
This prospective, randomized, double-blind, placebo-controlled study was designed to investigate the effects of preemptive intravenous ibuprofen on neurocognitive recovery, pain management, and the quality of recovery in geriatric patients. The study included 76 male patients, aged 65-84 years, with an ASA physical status of I-III, scheduled for elective open inguinal hernia repair.
Study Protocol:
Patients were randomly assigned into two equal groups (n=38 each) using a sealed envelope method:
- Ibuprofen Group (Group 1): Received 800 mg of intravenous ibuprofen (diluted in 200 mL of 0.9% NaCl) administered via infusion 30 minutes before anesthesia induction.
- Control Group (Group 2): Received 200 mL of 0.9% NaCl (placebo) administered via infusion 30 minutes before anesthesia induction.
Anesthesia and Monitoring:
A standardized general anesthesia protocol was applied to all participants. Monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Additionally, the Bispectral Index (BIS) was used to monitor anesthesia depth (target: 40-60), and Near-Infrared Spectroscopy (NIRS) was utilized to monitor bilateral cerebral oxygenation.
Outcomes and Assessments:
- Neurocognitive Recovery: The Montreal Cognitive Assessment (MoCA) was used to evaluate cognitive functions at three time points: 24 hours preoperatively (baseline), on postoperative day 1 (POD1), and on postoperative day 7 (POD7). Delayed Neurocognitive Recovery (dNCR) was defined as a decrease of \ge2 points in the MoCA score compared to baseline.
- Analgesic Requirement: Postoperative pain intensity was measured using the Visual Analog Scale (VAS) at rest and during movement at the 1st, 6th, 12th, and 24th hours. Total opioid (tramadol) consumption and the need for rescue analgesia were recorded over the first 24 hours.
- Quality of Recovery: Subjective recovery quality was assessed on the first postoperative day using the Quality of Recovery-15 (QoR-15) scale, which evaluates physical and emotional well-being.
The study hypothesizes that preemptive ibuprofen administration mitigates the systemic inflammatory response triggered by surgery, thereby reducing neuroinflammation, decreasing postoperative opioid reliance, and improving the overall quality of recovery for elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen Group | Experimental | Drug: Ibuprofen (400 mg x 4)Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 800 mg intravenous ibuprofen before anesthesia induction. |
| Control Group | Placebo comparator | Other: Placebo (NaCl 0.9 % solution)Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 200 mL 0.9% NaCl (saline) before anesthesia induction. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male patients between the ages of 65 and 84.
- ASA (American Society of Anesthesiologists) physical status I - III.
- Preoperative Mini-Mental State Examination (MMSE) score of \ge24.
- Undergoing elective (non-emergency) open inguinal hernia repair using the
- Lichtenstein tension-free method with mesh.
Key exclusion criteria (10 listed)
- Illiterate patients.
- History of active alcoholism or substance abuse.
- Neuro-psychiatric disorders such as Parkinson's, Alzheimer's, vascular dementia, advanced stroke sequelae, schizophrenia, or major depressive disorder.
- Active metastatic cancer or terminal illness.
- Known allergy to nonsteroidal anti-inflammatory drugs (especially ibuprofen), acetylsalicylic acid, or other drugs used in the study.
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 |
|---|---|---|
| Ibuprofen (400 mg x 4)Also: Dorifen®800 mg intravenous infusion, administered 30 minutes before anesthesia induction. | Drug | Ibuprofen Group |
| Placebo (NaCl 0.9 % solution)200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction. | Other | Control Group |
Primary outcome
Montreal Cognitive Assessment (MoCA) Score.
Time frame: Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7.
The MoCA is a 30-point tool used to evaluate cognitive domains such as memory, attention, and executive functions. A decline of ≥ 2 points from the preoperative baseline is defined as the occurrence of Delayed Neurocognitive Recovery (dNCR).
4 secondary outcomes
Visual Analog Scale (VAS) Score.
Time frame: Postoperative 1st, 6th, 12th, and 24th hours.
Total Postoperative Tramadol Consumption.
Time frame: Postoperative 24 hours.
Quality of Recovery-15 (QoR-15) Score.
Time frame: Postoperative Day 1.
Regional Cerebral Oxygen Saturation (rScO2).
Time frame: From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals).
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 3 Mar 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected during the study will not be shared with external researchers to protect participant confidentiality and comply with the institutional ethics committee guidelines. Only aggregated data and statistical results presented in the final thesis and related publications will be made available.
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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?
A Phase 4 study testing Ibuprofen (400 mg x 4) in people with Inguinal Hernia Unilateral and Delayed Neurocognitive Recovery, run by Mehmet Çiğdem 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 6 inclusion and 10 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 3 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Montreal Cognitive Assessment (MoCA) Score. (time frame: Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7.). 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 Mar 2026.