Effect of Maxigesic on Delirium in Elderly After Lung Surgery
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
PHASE4 · Korea University Guro Hospital · NCT05834569
This study is testing if a pain relief medication called Maxigesic can help prevent confusion and delirium in older adults after they have lung surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Korea University Guro Hospital (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05834569 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the effects of Maxigesic, a combination of acetaminophen and ibuprofen, on the incidence and severity of postoperative delirium in elderly patients undergoing minimally invasive lung surgery. Participants aged 65 and older will receive either Maxigesic or a placebo (normal saline) during the perioperative period. The study will monitor patients for 5 days post-surgery to evaluate any changes in delirium symptoms. The goal is to determine if Maxigesic can effectively reduce the occurrence of delirium in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years or older scheduled for minimally invasive lung lobectomy or segmentectomy.
Not a fit: Patients with severe pre-existing health conditions or those with hypersensitivity to the ingredients in Maxigesic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced incidence of delirium in elderly patients after lung surgery.
How similar studies have performed: Other studies have shown promising results with similar perioperative analgesic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy Exclusion Criteria: * 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
Where this trial is running
Seoul
- Korea University Guro Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Heezoo Kim, MD, PhD — Korea University Guro Hospital
- Study coordinator: Heezoo KIM, MD, PhD
- Email: kimheezoo@gmail.com
- Phone: 82-2-2626-1437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delirium, Aged, Lung Neoplasms, Robotic Surgical Procedures, Thoracic Surgery, Video-Assisted, Postoperative delirium, Elderly, Minimally invasive surgery