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Clinical Trials/NCT05834569
NCT05834569TerminatedPhase 4

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

Korea University Guro Hospital1 site in 1 country25 target enrollmentStarted: June 15, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
25
Locations
1
Primary Endpoint
Incidence of postoperative delirium(POD)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Maxigesic group

Experimental

Intervention: Acetaminophen and Ibuprofen (Drug)

Control group

Placebo Comparator

Intervention: Normal saline (Drug)

Outcomes

Primary Outcomes

Incidence of postoperative delirium(POD)

Time Frame: From immediately after surgery to 5 days after surgery

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.

Secondary Outcomes

  • ICU stay(Immediately after surgery to ICU discharge(usually within about 5 days after surgery))
  • Postoperative nausea, vomiting(Immediately after surgery to postoperative 48 hours)
  • Hospital stay(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))
  • Severity of POD(From immediately after surgery to 5 days after surgery)
  • Postoperative pain(Immediately after surgery to postoperative 48 hours)
  • Consumption of opioids(Immediately after surgery to postoperative 48 hours)
  • Postoperative complications(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))
  • Duration of POD(From immediately after surgery to 5 days after surgery)
  • Preoperative cognition(1 day before surgery)
  • Preoperative frailty(1 day before surgery)
  • Drug side effects(Immediately after surgery to hospital discharge(usually within about 30 days after surgery))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kim, Heezoo

Professor

Korea University Guro Hospital

Study Sites (1)

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