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NCT Number: NCT07424001

Preemptive IV Ibuprofen for Neurocognitive Recovery and Analgesic Needs After 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:

* 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.

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Key information

Age range

65 year–84 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, Kadıköy, 34710, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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%).
  • 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.

Treatment and study plan

Ibuprofen (400 mg x 4)

Drug

800 mg intravenous infusion, administered 30 minutes before anesthesia induction.

Other names: Dorifen®

Placebo (NaCl 0.9 % solution)

Other

200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Visual Analog Scale (VAS) Score.

    Time frame: Postoperative 1st, 6th, 12th, and 24th hours.

    Pain intensity measured on a scale from 0 (no pain) to 10 (unbearable pain).

  2. Total Postoperative Tramadol Consumption.

    Time frame: Postoperative 24 hours.

    The cumulative amount of intravenous tramadol (in milligrams) administered for pain management over the first 24 hours after surgery.

  3. Quality of Recovery-15 (QoR-15) Score.

    Time frame: Postoperative Day 1.

    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).

  4. 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).

    Measured via Near-Infrared Spectroscopy (NIRS) to monitor bilateral frontal lobe oxygenation during surgery.

Sponsors and collaborators

Lead sponsor

Mehmet Çiğdem

Other

Collaborators

  • Goztepe Prof Dr Suleyman Yalcın City Hospital

Registry information

Official study title

Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery

Acronym: IBU-COG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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