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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834569
• Other study ID #: 2023GR0023
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Korea University Guro Hospital
• Contact: Heezoo KIM, MD, PhD
• Phone: 82-2-2626-1437
• Email: kimheezoo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Delirium
• Lung Neoplasms
• Robotic Surgical Procedures
• Thoracic Surgery, Video-Assisted

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Kyongbo Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Consumption of opioids	Opioid consumption is measured by converting them into morphine equivalents.	Immediately after surgery to postoperative 48 hours
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Postoperative complications	Investigate all kinds of complications that occur after surgery.	Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Secondary	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)