DeliriumPhase 4NCT05834569
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
A Phase 4 study testing Acetaminophen and Ibuprofen and Normal saline in people with Delirium and Aged, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Aged, Lung Neoplasms
- What is being tested?
- Acetaminophen and Ibuprofen and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2023to 23 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Delirium, Aged, Lung Neoplasms, Robotic Surgical Procedures, Thoracic Surgery, Video-Assisted
- Being tested
- Acetaminophen and Ibuprofen, Normal saline
- Keywords
- Postoperative delirium, Elderly, Minimally invasive surgery, Lung segmentectomy, Lung lobectomy
- Medical subject headings
- Delirium, Lung Neoplasms, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Normal salineDrug
Patients in the control group will be administered equal amounts of normal saline at the same time points.
| Study group | Role | What they receive |
|---|---|---|
| Maxigesic group | Experimental | Not described Receives: Drug: Acetaminophen and Ibuprofen |
| Control group | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From immediately after surgery to 5 days after surgery
Secondary outcomes (12)
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.)
Measured: 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.
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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).
Measured: Immediately after surgery to postoperative 48 hours
Consumption of opioids
Opioid consumption is measured by converting them into morphine equivalents.
Measured: 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.
Measured: Immediately after surgery to postoperative 48 hours
ICU stay
Determine how many days the participant stays in the ICU.
Measured: 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.
Measured: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Postoperative complications
Investigate all kinds of complications that occur after surgery.
Measured: 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.
Measured: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start15 Jun 2023
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Why it stopped: The study was terminated early owing to challenges in completing the research registration process.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyongbo Pharmaceutical Co.,Ltd
- Responsible party
- Principal investigator, Kim, Heezoo, Korea University Guro Hospital
- Investigators
- Heezoo Kim, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834569
- Sponsor's protocol ID
- 2023GR0023
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have no plans yet to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05834569
- Acronym / sponsor ID
- 2023GR0023
- Conditions
- Delirium, Aged, Lung Neoplasms, Robotic Surgical Procedures, Thoracic Surgery, Video-Assisted
- Keywords
- Postoperative delirium, Elderly, Minimally invasive surgery, Lung segmentectomy, Lung lobectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early owing to challenges in completing the research registration process.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Kyongbo Pharmaceutical Co.,Ltd
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxigesic group | Experimental | Drug: Acetaminophen and Ibuprofen |
| Control group | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen and IbuprofenPatients 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. | Drug | Maxigesic group |
| Normal salinePatients in the control group will be administered equal amounts of normal saline at the same time points. | Drug | Control group |
Primary outcome
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.
12 secondary outcomes
Severity of POD
Time frame: From immediately after surgery to 5 days after surgery
Duration of POD
Time frame: From immediately after surgery to 5 days after surgery
Preoperative cognition
Time frame: 1 day before surgery
Preoperative cognition
Time frame: 1 day before surgery
Preoperative frailty
Time frame: 1 day before surgery
Postoperative pain
Time frame: Immediately after surgery to postoperative 48 hours
Consumption of opioids
Time frame: Immediately after surgery to postoperative 48 hours
Postoperative nausea, vomiting
Time frame: Immediately after surgery to postoperative 48 hours
ICU stay
Time frame: Immediately after surgery to ICU discharge(usually within about 5 days after surgery)
Hospital stay
Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Postoperative complications
Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Drug side effects
Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Results and safety
The study was stopped early (reason given: The study was terminated early owing to challenges in completing the research registration process.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No. The investigators have no plans yet to share individual participant data (IPD) with other researchers.
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heezoo Kim, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Ibuprofen and Normal saline in people with Delirium and Aged, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early owing to challenges in completing the research registration process.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium(POD) (time frame: From immediately after surgery to 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.