{
"info": {
"nct_id": "NCT03012984",
"official_title": "Impact of Dexmedetomidine Supplemented Analgesia on Incidence of Delirium in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial",
"inclusion_criteria": "* Age >= 65 years, < 90 years;\n* Scheduled to undergo surgery for primary solid organ cancer under general anesthesia, with an expected duration of surgery >=2 hours;\n* Planned to use patient-controlled intravenous analgesia after surgery;\n* Provide written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 65 Years\nMust have maximum age of 90 Years",
"exclusion_criteria": "* Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;\n* Preoperative radio- or chemotherapy;\n* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;\n* Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score >= 3);\n* Brain trauma or neurosurgery;\n* Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;\n* Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery);\n* ASA classification >= IV.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age >= 65 years, < 90 years;",
"criterions": [
{
"exact_snippets": "Age >= 65 years, < 90 years",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 65,
"unit": "years"
},
{
"operator": "<",
"value": 90,
"unit": "years"
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]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"requirement": {
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"expected_value": {
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"value": 65,
"unit": "years"
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"value": 90,
"unit": "years"
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}
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}
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}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Scheduled to undergo surgery for primary solid organ cancer",
"criterion": "surgery for primary solid organ cancer",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "under general anesthesia",
"criterion": "general anesthesia",
"requirement": {
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"expected_value": true
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},
{
"exact_snippets": "expected duration of surgery >=2 hours",
"criterion": "duration of surgery",
"requirement": {
"requirement_type": "expected duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "hours"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Scheduled to undergo surgery for primary solid organ cancer",
"criterion": "surgery for primary solid organ cancer",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "under general anesthesia",
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"requirement": {
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"expected_value": true
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{
"exact_snippets": "expected duration of surgery >=2 hours",
"criterion": "duration of surgery",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "hours"
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}
}
]
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},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Planned to use patient-controlled intravenous analgesia after surgery",
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"requirement": {
"requirement_type": "planned",
"expected_value": true
}
}
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"logical_structure": {
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"exact_snippets": "Planned to use patient-controlled intravenous analgesia after surgery",
"criterion": "use of patient-controlled intravenous analgesia",
"requirement": {
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"expected_value": true
}
}
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}
},
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"line": "* Provide written informed consent.",
"criterions": [
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"expected_value": true
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}
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{
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}
},
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"exact_snippets": "minimum age of 65 Years",
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"unit": "Years"
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"unit": "Years"
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},
{
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"exact_snippets": "maximum age of 90 Years",
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"expected_value": {
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"value": 90,
"unit": "Years"
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}
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"value": 90,
"unit": "Years"
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}
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],
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"requirement": {
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"expected_value": true
}
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{
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"criterion": "parkinsonism",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Preoperative history of ... myasthenia gravis",
"criterion": "myasthenia gravis",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "schizophrenia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Preoperative history of ... epilepsy",
"criterion": "epilepsy",
"requirement": {
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"expected_value": true
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{
"exact_snippets": "Preoperative history of ... parkinsonism",
"criterion": "parkinsonism",
"requirement": {
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"expected_value": true
}
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{
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"criterion": "myasthenia gravis",
"requirement": {
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"expected_value": true
}
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]
}
},
{
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"criterions": [
{
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Inability to communicate ... because of ... profound dementia",
"criterion": "profound dementia",
"requirement": {
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"expected_value": true
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{
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"expected_value": true
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"expected_value": true
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{
"and_criteria": [
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{
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"expected_value": true
}
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{
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{
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"expected_value": true
}
},
{
"exact_snippets": "STOP-Bang score >= 3",
"criterion": "STOP-Bang score",
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "N/A"
}
}
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"expected_value": true
}
}
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{
"and_criteria": [
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"exact_snippets": "STOP-Bang score >= 3",
"criterion": "STOP-Bang score",
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"value": 3,
"unit": "N/A"
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}
}
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"identified_line": {
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"exact_snippets": "Brain trauma",
"criterion": "brain trauma",
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"expected_value": true
}
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{
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{
"identified_line": {
"line": "* Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;",
"criterions": [
{
"exact_snippets": "Preoperative left ventricular ejection fraction < 30%",
"criterion": "left ventricular ejection fraction",
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"expected_value": {
"operator": "<",
"value": 30,
"unit": "%"
}
}
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"expected_value": true
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{
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"requirement": {
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"expected_value": "severe"
}
},
{
"exact_snippets": "severe sinus bradycardia (< 50 beats per minute)",
"criterion": "sinus bradycardia",
"requirement": {
"requirement_type": "heart rate",
"expected_value": {
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"value": 50,
"unit": "beats per minute"
}
}
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{
"exact_snippets": "second-degree or above atrioventricular block without pacemaker",
"criterion": "atrioventricular block",
"requirement": {
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"expected_value": "second-degree or above"
}
},
{
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"criterion": "atrioventricular block",
"requirement": {
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}
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"unit": "%"
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}
}
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}
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"value": 50,
"unit": "beats per minute"
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"requirement": {
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{
"identified_line": {
"line": "* Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery);",
"criterions": [
{
"exact_snippets": "Severe hepatic dysfunction (Child-Pugh class C)",
"criterion": "hepatic dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe hepatic dysfunction (Child-Pugh class C)",
"criterion": "hepatic dysfunction",
"requirement": {
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}
},
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"exact_snippets": "severe renal dysfunction (requirement of renal replacement therapy before surgery)",
"criterion": "renal dysfunction",
"requirement": {
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},
{
"exact_snippets": "severe renal dysfunction (requirement of renal replacement therapy before surgery)",
"criterion": "renal dysfunction",
"requirement": {
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"expected_value": "renal replacement therapy before surgery"
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}
]
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"logical_structure": {
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"and_criteria": [
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"exact_snippets": "Severe hepatic dysfunction (Child-Pugh class C)",
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"requirement": {
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}
},
{
"exact_snippets": "Severe hepatic dysfunction (Child-Pugh class C)",
"criterion": "hepatic dysfunction",
"requirement": {
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}
}
]
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"and_criteria": [
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"exact_snippets": "severe renal dysfunction (requirement of renal replacement therapy before surgery)",
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"requirement": {
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}
},
{
"exact_snippets": "severe renal dysfunction (requirement of renal replacement therapy before surgery)",
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"requirement": {
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}
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]
}
},
{
"identified_line": {
"line": "* ASA classification >= IV.",
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"exact_snippets": "ASA classification >= IV",
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"expected_value": {
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"value": 4,
"unit": "N/A"
}
}
}
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},
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"unit": "N/A"
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}
}
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
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{
"exact_snippets": "Preoperative radio- or chemotherapy",
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"exact_snippets": "Preoperative radio- or chemotherapy",
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}
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],
"failed_miscellaneous": []
}