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

Phase 4

Recruiting

• Conditions: Lung Neoplasms; Robotic Surgical Procedures; Thoracic Surgery, Video-Assisted; Delirium; Aged
• Interventions: Drug: Acetaminophen and Ibuprofen; Drug: Normal saline

• Registration Number: NCT05834569
• Lead Sponsor: Korea University Guro Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-28
• Study Start: 2023-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxigesic group	Acetaminophen and Ibuprofen	-
Control group	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium(POD)	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 Outcome Measures

Name	Time	Method
ICU stay	Immediately after surgery to ICU discharge(usually within about 5 days after surgery)	Determine how many days the participant stays in the ICU.
Postoperative nausea, vomiting	Immediately after surgery to postoperative 48 hours	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.
Hospital stay	Immediately after surgery to hospital discharge(usually within about 30 days after surgery)	Determine how many days the participant stays in the hospital.
Severity of POD	From immediately after surgery to 5 days after surgery	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.)
Postoperative pain	Immediately after surgery to postoperative 48 hours	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).
Consumption of opioids	Immediately after surgery to postoperative 48 hours	Opioid consumption is measured by converting them into morphine equivalents.
Postoperative complications	Immediately after surgery to hospital discharge(usually within about 30 days after surgery)	Investigate all kinds of complications that occur after surgery.
Duration of POD	From immediately after surgery to 5 days after surgery	CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.
Preoperative cognition	1 day before surgery	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.)
Preoperative frailty	1 day before surgery	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.)
Drug side effects	Immediately after surgery to hospital discharge(usually within about 30 days after surgery)	Investigate complications suspected to be side effects caused by the study drug.

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of