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The study was terminated early owing to challenges in completing the research registration process.
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| Name | Class |
|---|---|
| Kyongbo Pharmaceutical Co.,Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxigesic group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen and Ibuprofen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of POD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heezoo Kim, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
The investigators have no plans yet to share individual participant data (IPD) with other researchers.
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D008175 | Lung Neoplasms |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline | Drug | Patients in the control group will be administered equal amounts of normal saline at the same time points. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Consumption of opioids | Opioid consumption is measured by converting them into morphine equivalents. | 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. | Immediately after surgery to postoperative 48 hours |
| 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) |
| 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) |
| Postoperative complications | Investigate all kinds of complications that occur after surgery. | 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. | Immediately after surgery to hospital discharge(usually within about 30 days after surgery) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |