Overview

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

Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korea University Guro Hospital
Collaborator:
Kyongbo Pharmaceutical Co.,Ltd
Treatments:
Acetaminophen
Ibuprofen
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