Clinical trial NCT05834569: Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Delirium
Aged
Lung Neoplasms
Robotic Surgical Procedures
Thoracic Surgery, Video-Assisted
Keywords: Postoperative delirium
Elderly
Minimally invasive surgery
Lung segmentectomy
Lung lobectomy
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Kyongbo Pharmaceutical Co.,Ltd
First posted: 2023-04-28
Enrollment: 176
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Incidence of postoperative delirium(POD)
timeFrame: From immediately after surgery to 5 days after surgery
Secondary outcomes:
measure: Severity of POD
timeFrame: From immediately after surgery to 5 days after surgery
measure: Duration of POD
timeFrame: From immediately after surgery to 5 days after surgery
measure: Preoperative cognition
timeFrame: 1 day before surgery
measure: Preoperative cognition
timeFrame: 1 day before surgery
measure: Preoperative frailty
timeFrame: 1 day before surgery
measure: Postoperative pain
timeFrame: Immediately after surgery to postoperative 48 hours
measure: Consumption of opioids
timeFrame: Immediately after surgery to postoperative 48 hours
measure: Postoperative nausea, vomiting
timeFrame: Immediately after surgery to postoperative 48 hours
measure: ICU stay
timeFrame: Immediately after surgery to ICU discharge(usually within about 5 days after surgery)
measure: Hospital stay
timeFrame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
measure: Postoperative complications
timeFrame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
measure: Drug side effects
timeFrame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Heezoo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: