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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Lung Neoplasms; Aged; Robotic Surgical Procedures; Thoracic Surgery, Video-Assisted
• Intervention / Treatment: Drug: Acetaminophen and Ibuprofen; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hye Bin Kim, MD, PhD; Phone Number: 82-10-9183-5617; Email: aneshbkim@gmail.com
• Study Contact Backup: Name: Heezoo KIM, MD, PhD; Phone Number: 82-2-2626-1437; Email: kimheezoo@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Hye Bin Kim, MD, PhD; Phone Number: 82-2-2626-1437; Email: anesbhkim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Drug: Normal saline; Patients in the control group will be administered equal amounts of normal saline at the same time points.
Experimental: Maxigesic group	Drug: Acetaminophen and Ibuprofen; 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.

What is the study measuring?

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
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)
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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Kyongbo Pharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Heezoo Kim, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Minimally invasive surgery; Postoperative delirium; Lung segmentectomy; Lung lobectomy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Delirium; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 2023GR0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators have no plans yet to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No