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

Korea University

Status and phase

Enrolling

Phase 4

Conditions

Lung Neoplasms

Delirium

Thoracic Surgery, Video-Assisted

Robotic Surgical Procedures

Aged

Treatments

Drug: Acetaminophen and Ibuprofen

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05834569

2023GR0023

Details and patient eligibility

About

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.

Enrollment

176 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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