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| ID | Type | Description | Link |
|---|---|---|---|
| E-24931227-514.04.02-5738966 | Other Identifier | Republic of Türkiye Ministry of Health - Turkish Medicines and Medical Devices Agency (TITCK) |
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| Name | Class |
|---|---|
| Goztepe Prof Dr Suleyman Yalcın City Hospital | OTHER |
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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:
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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen Group | Experimental | 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 | Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 200 mL 0.9% NaCl (saline) before anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen (400 mg x 4) | Drug | 800 mg intravenous infusion, administered 30 minutes before anesthesia induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Score. | Pain intensity measured on a scale from 0 (no pain) to 10 (unbearable pain). | Postoperative 1st, 6th, 12th, and 24th hours. |
| Total Postoperative Tramadol Consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi | Istanbul | Kadıköy | 34710 | Turkey (Türkiye) |
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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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A prospective, randomized, double-blind, placebo-controlled clinical trial. Participants were assigned to either an experimental group receiving 800 mg IV ibuprofen or a control group receiving 0.9% NaCl, both administered 30 minutes prior to anesthesia induction.
| Placebo (NaCl 0.9 % solution) | Other | 200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction. |
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The cumulative amount of intravenous tramadol (in milligrams) administered for pain management over the first 24 hours after surgery.
| 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). | Postoperative Day 1. |
| Regional Cerebral Oxygen Saturation (rScO2). | Measured via Near-Infrared Spectroscopy (NIRS) to monitor bilateral frontal lobe oxygenation during surgery. | From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals). |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004364 | Pharmaceutical Preparations |
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