The Impact of Intravenous Administration of Perioperative Acetaminophen and Ibuprofen Combination (Maxigesic®) on Postoperative Delirium in Elderly Patients Undergoing Minimally Invasive Lung Segmentectomy or Lobectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium(POD)
研究概览
简要总结
The primary aim of this interventional study is to investigate the impact of perioperative administration of Maxigesic (combination of acetaminophen and ibuprofen) on delirium after minimally invasive lung surgery in elderly patients. The Maxigesic group receives a total of 5 doses of Maxigesic (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthesia induction. The control group receives the same volume of normal saline. Researchers compare the incidence and severity of postoperative delirium for 5 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy
排除标准
- •Hypersensitivity to the main ingredients and additives of Maxigesic
- •Hypersensitivity to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Alcoholism / Alcohol intoxication
- •Severe hematological abnormalities
- •Bleeding tendency (e.g., Spontaneous bleeding)
- •Severe hepatic dysfunction (AST, AST ≥2.5 * upper normal limit(UNL) or Total bilirubin ≥3.0 mg/dl)
- •Severe renal dysfunction (eGFR <30 ml/min/1.73m2 or Dialysis)
- •Severe heart failure (Left ventricle ejection fraction <30%)
- •Uncontrolled hypertension(HTN) (Systolic blood pressure >180 mmHg)
- •Symptomatic asthma in need of treatment
- •Anticoagulants or antiplatelet agents are maintained for up to 5 days before surgery
- •Barbiturates or tricyclic antidepressants (TCAs)
- •High-dose methotrexate (MTX) for cancer treatment
- •Preoperative cognitive impairment, dementia, or delirium
- •Inability to understand the research and instructions for this study
研究组 & 干预措施
Maxigesic group
干预措施: Acetaminophen and Ibuprofen (Drug)
Control group
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of postoperative delirium(POD)
时间窗: From immediately after surgery to 5 days after surgery
Confusion assessment method(CAM)/Confusion Assessment Method for the ICU (CAM-ICU) or delirium record on electrical medical record(EMR) will be used for the evaluation of POD.
次要结局
- ICU stay(Immediately after surgery to ICU discharge(usually within about 5 days after surgery))
- Postoperative nausea, vomiting(Immediately after surgery to postoperative 48 hours)
- Hospital stay(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))
- Severity of POD(From immediately after surgery to 5 days after surgery)
- Postoperative pain(Immediately after surgery to postoperative 48 hours)
- Consumption of opioids(Immediately after surgery to postoperative 48 hours)
- Postoperative complications(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))
- Duration of POD(From immediately after surgery to 5 days after surgery)
- Preoperative cognition(1 day before surgery)
- Preoperative frailty(1 day before surgery)
- Drug side effects(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))
研究者
Kim, Heezoo
Professor
Korea University Guro Hospital