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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Delirium, Aged, Lung Neoplasms, Robotic Surgical Procedures, Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Drug: Acetaminophen and Ibuprofen
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxigesic group<br> | Drug: Acetaminophen and Ibuprofen<br>* Patients in the Maxigesic group will be administered a total of 5 doses of the drug (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthetic induction.<br>|
| Placebo Comparator: Control group<br> | Drug: Normal saline<br>* Patients in the control group will be administered equal amounts of normal saline at the same time points.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium(POD) | Confusion assessment method(CAM)/Confusion Assessment Method for the ICU (CAM-ICU) or delirium record on electrical medical record(EMR) will be used for the evaluation of POD. | From immediately after surgery to 5 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of POD | CAM-S(severity) will be utilized to assess the severity of POD. (*CAM-S is measured on 0-7 (short form) and 0-19 (long form) scale, and the higher the score, the greater the POD severity.) | From immediately after surgery to 5 days after surgery | 
| Duration of POD | CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD. | From immediately after surgery to 5 days after surgery | 
| Preoperative cognition | Mini-mental state examination(MMSE) will be used to evaluate the participants' preoperative cognition. (*MMSE is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.) | 1 day before surgery | 
| Preoperative cognition | Montreal cognitive assessment(MoCA) will be used to evaluate the participants' preoperative cognition. (*MoCA is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.) | 1 day before surgery | 
| Preoperative frailty | Clinical frailty scale(CFS) will be utilized to assess the preoperative frailty (*CFS is used to determine comprehensive geriatric assessment. It is measured on 1-9 scale, and the higher the scale, the more frail the patient is.) | 1 day before surgery | 
| Postoperative pain | Numerical rating scale (NRS) or Visual analogue scale (VAS) will be used to determine the postoperative pain severity (*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain. If the patient can verbalize their pain, use the NRS; otherwise, use the VAS to assess pain). | Immediately after surgery to postoperative 48 hours | 
| Consumption of opioids | Opioid consumption is measured by converting them into morphine equivalents. | Immediately after surgery to postoperative 48 hours | 
| Postoperative nausea, vomiting | Nausea is measured by scoring on a scale of 0-10. The higher the score, the more severe the symptom. Whether the patients vomit or not is observed and recorded. | Immediately after surgery to postoperative 48 hours | 
| ICU stay | Determine how many days the participant stays in the ICU. | Immediately after surgery to ICU discharge(usually within about 5 days after surgery) | 
| Hospital stay | Determine how many days the participant stays in the hospital. | Immediately after surgery to hospital discharge(usually within about 30 days after surgery) | 
| Postoperative complications | Investigate all kinds of complications that occur after surgery. | Immediately after surgery to hospital discharge(usually within about 30 days after surgery) | 
| Drug side effects | Investigate complications suspected to be side effects caused by the study drug. | Immediately after surgery to hospital discharge(usually within about 30 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative delirium, Elderly, Minimally invasive surgery, Lung segmentectomy, Lung lobectomy