NCT07424001

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 15, 2026

Last Update Submit

March 1, 2026

Conditions

Inguinal Hernia UnilateralDelayed Neurocognitive RecoveryPostoperative PainNeuroinflammationPreemptive Analgesia

Keywords

IbuprofenPreemptive AnalgesiaGeriatric PatientsQuality of RecoveryMontreal Cognitive Assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • Visual Analog Scale (VAS) Score.

    Postoperative 1st, 6th, 12th, and 24th hours.

  • Total Postoperative Tramadol Consumption.

    Postoperative 24 hours.

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

    Postoperative Day 1.

  • Regional Cerebral Oxygen Saturation (rScO2).

    From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals).

Study Arms (2)

Ibuprofen Group

EXPERIMENTAL

Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 800 mg intravenous ibuprofen before anesthesia induction.

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.

Other: Placebo (NaCl 0.9 % solution)

Interventions

Ibuprofen (400 mg x 4)DRUG

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

Also known as: Dorifen®
Ibuprofen Group
Placebo (NaCl 0.9 % solution)OTHER

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

Control Group

Eligibility Criteria

Age65 Years - 84 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, Kadıköy, 34710, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pain, PostoperativeNeuroinflammatory Diseases

Interventions

IbuprofenSolutions

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNervous System DiseasesInflammation

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 20, 2026

Study Start

September 27, 2025

Primary Completion

January 22, 2026

Study Completion

January 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)