Back to resultsImpact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
Primary Purpose
Delirium, Aged, Lung Neoplasms
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetaminophen and Ibuprofen
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Postoperative delirium, Elderly, Minimally invasive surgery, Lung segmentectomy, Lung lobectomy
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
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Maxigesic group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.)
Duration of POD
CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.
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.)
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.)
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.)
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).
Consumption of opioids
Opioid consumption is measured by converting them into morphine equivalents.
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.
ICU stay
Determine how many days the participant stays in the ICU.
Hospital stay
Determine how many days the participant stays in the hospital.
Postoperative complications
Investigate all kinds of complications that occur after surgery.
Drug side effects
Investigate complications suspected to be side effects caused by the study drug.
Full Information
NCT ID
NCT05834569
First Posted
March 7, 2023
Last Updated
September 3, 2023
Sponsor
Korea University Guro Hospital
Collaborators
Kyongbo Pharmaceutical Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05834569
Brief Title
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
Collaborators
Kyongbo Pharmaceutical Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Aged, Lung Neoplasms, Robotic Surgical Procedures, Thoracic Surgery, Video-Assisted
Keywords
Postoperative delirium, Elderly, Minimally invasive surgery, Lung segmentectomy, Lung lobectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maxigesic group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetaminophen and Ibuprofen
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Patients in the control group will be administered equal amounts of normal saline at the same time points.
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium(POD)
Description
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.
Time Frame
From immediately after surgery to 5 days after surgery
Secondary Outcome Measure Information:
Title
Severity of POD
Description
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.)
Time Frame
From immediately after surgery to 5 days after surgery
Title
Duration of POD
Description
CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.
Time Frame
From immediately after surgery to 5 days after surgery
Title
Preoperative cognition
Description
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.)
Time Frame
1 day before surgery
Title
Preoperative cognition
Description
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.)
Time Frame
1 day before surgery
Title
Preoperative frailty
Description
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.)
Time Frame
1 day before surgery
Title
Postoperative pain
Description
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).
Time Frame
Immediately after surgery to postoperative 48 hours
Title
Consumption of opioids
Description
Opioid consumption is measured by converting them into morphine equivalents.
Time Frame
Immediately after surgery to postoperative 48 hours
Title
Postoperative nausea, vomiting
Description
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.
Time Frame
Immediately after surgery to postoperative 48 hours
Title
ICU stay
Description
Determine how many days the participant stays in the ICU.
Time Frame
Immediately after surgery to ICU discharge(usually within about 5 days after surgery)
Title
Hospital stay
Description
Determine how many days the participant stays in the hospital.
Time Frame
Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Title
Postoperative complications
Description
Investigate all kinds of complications that occur after surgery.
Time Frame
Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
Title
Drug side effects
Description
Investigate complications suspected to be side effects caused by the study drug.
Time Frame
Immediately after surgery to hospital discharge(usually within about 30 days after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heezoo KIM, MD, PhD
Phone
82-2-2626-1437
Email
kimheezoo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Bin KIM, MD, PhD
Phone
82-10-9183-5617
Email
aneshbkim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heezoo Kim, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Bin Kim, MD, PhD
Phone
82-2-2626-1437
Email
anesbhkim@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators have no plans yet to share individual participant data (IPD) with other researchers.
Learn more about this trial
Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients
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