Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA) Score.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients between the ages of 65 and
- •ASA (American Society of Anesthesiologists) physical status I - III.
- •Preoperative Mini-Mental State Examination (MMSE) score of \ge
- •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.
排除标准
- •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.
研究组 & 干预措施
Ibuprofen Group
Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 800 mg intravenous ibuprofen before anesthesia induction.
干预措施: Ibuprofen (400 mg x 4) (Drug)
Control Group
Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 200 mL 0.9% NaCl (saline) before anesthesia induction.
干预措施: Placebo (NaCl 0.9 % solution) (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA) Score.
时间窗: 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).
次要结局
- 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).)
研究者
Mehmet Çiğdem
Anesthesiologist
Istanbul Medeniyet University