NCT05834569

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

March 7, 2023

Last Update Submit

August 28, 2025

Conditions

DeliriumAgedLung NeoplasmsRobotic Surgical ProceduresThoracic Surgery, Video-Assisted

Keywords

Postoperative deliriumElderlyMinimally invasive surgeryLung segmentectomyLung lobectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Severity of POD

    From immediately after surgery to 5 days after surgery

  • Duration of POD

    From immediately after surgery to 5 days after surgery

  • Preoperative cognition

    1 day before surgery

  • Preoperative cognition

    1 day before surgery

  • Preoperative frailty

    1 day before surgery

  • +7 more secondary outcomes

Study Arms (2)

Maxigesic group

EXPERIMENTAL
Drug: Acetaminophen and Ibuprofen

Control group

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Acetaminophen and IbuprofenDRUG

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.

Maxigesic group
Normal salineDRUG

Patients in the control group will be administered equal amounts of normal saline at the same time points.

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

DeliriumLung NeoplasmsEmergence Delirium

Interventions

AcetaminophenIbuprofenSaline Solution

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Heezoo Kim, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2023

First Posted

April 28, 2023

Study Start

June 15, 2023

Primary Completion

January 23, 2025

Study Completion

January 23, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The investigators have no plans yet to share individual participant data (IPD) with other researchers.

Locations

KR(1)