Trials / Completed

CompletedNCT07424001

Preemptive IV Ibuprofen for Neurocognitive Recovery and Analgesic Needs After Inguinal Hernia Surgery

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

Status: Completed
Phase: Phase 4
Study type: Interventional
Enrollment: 76 (actual)

Sponsor: Mehmet Çiğdem · Academic / Other
Sex: Male
Age: 65 Years – 84 Years
Healthy volunteers: Not accepted

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.

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: 1. 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. 2. 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

Interventions

Type	Name	Description
DRUG	Ibuprofen (400 mg x 4)	800 mg intravenous infusion, administered 30 minutes before anesthesia induction.
OTHER	Placebo (NaCl 0.9 % solution)	200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.

Timeline

Start date: 2025-09-27
Primary completion: 2026-01-22
Completion: 2026-01-30
First posted: 2026-02-20
Last updated: 2026-03-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07424001. Inclusion in this directory is not an endorsement.