Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul, Kadıköy, 34710, Turkey (Türkiye)
NCT Number: NCT07424001
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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Notify Me65 year–84 year
Male
Interventional
Phase 4
Istanbul, Kadıköy, 34710, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
800 mg intravenous infusion, administered 30 minutes before anesthesia induction.
Other names: Dorifen®
200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.
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).
Time frame: Postoperative 1st, 6th, 12th, and 24th hours.
Pain intensity measured on a scale from 0 (no pain) to 10 (unbearable pain).
Time frame: Postoperative 24 hours.
The cumulative amount of intravenous tramadol (in milligrams) administered for pain management over the first 24 hours after surgery.
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).
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.
Mehmet Çiğdem
Other
Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery
Acronym: IBU-COG
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