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Trial Title:
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
NCT ID:
NCT05834569
Condition:
Delirium
Aged
Lung Neoplasms
Robotic Surgical Procedures
Thoracic Surgery, Video-Assisted
Conditions: Official terms:
Lung Neoplasms
Delirium
Acetaminophen
Ibuprofen
Conditions: Keywords:
Postoperative delirium
Elderly
Minimally invasive surgery
Lung segmentectomy
Lung lobectomy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Acetaminophen and Ibuprofen
Description:
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.
Arm group label:
Maxigesic group
Intervention type:
Drug
Intervention name:
Normal saline
Description:
Patients in the control group will be administered equal amounts of normal saline at the
same time points.
Arm group label:
Control group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hye Bin Kim, MD, PhD
Phone:
82-2-2626-1437
Email:
anesbhkim@gmail.com
Start date:
June 15, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Korea University Guro Hospital
Agency class:
Other
Collaborator:
Agency:
Kyongbo Pharmaceutical Co.,Ltd
Agency class:
Other
Source:
Korea University Guro Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834569
