TerminatedPhase 4

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients

Stopped: The study was terminated early owing to challenges in completing the research registration process.

South Korea25 participantsStarted 2023-06-15

Plain-language summary

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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of postoperative delirium(POD)

Timeframe: From immediately after surgery to 5 days after surgery

Trial details

NCT IDNCT05834569

SponsorKorea University Guro Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-23

View on ClinicalTrials.gov More Delirium trials