{
    "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": [
        {
            "line": "* Age >= 65 years, < 90 years;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age >= 65 years, < 90 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 65
                            },
                            {
                                "operator": "<",
                                "value": 90
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Scheduled to undergo surgery for primary solid organ cancer under general anesthesia, with an expected duration of surgery >=2 hours;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Scheduled to undergo surgery"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "scheduled",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "primary solid organ cancer"
                    ],
                    "criterion": "primary solid organ cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "under general anesthesia"
                    ],
                    "criterion": "general anesthesia",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "expected duration of surgery >=2 hours"
                    ],
                    "criterion": "duration of surgery",
                    "requirement_type": "expected duration",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                }
            ]
        },
        {
            "line": "* Planned to use patient-controlled intravenous analgesia after surgery;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Planned to use patient-controlled intravenous analgesia after surgery"
                    ],
                    "criterion": "patient-controlled intravenous analgesia",
                    "requirement_type": "planned use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "form",
                    "expected_value": "written"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 65 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 65
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 90 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 90
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Preoperative radio- or chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Preoperative radio-"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "timing",
                    "expected_value": "preoperative"
                },
                {
                    "exact_snippets": [
                        "Preoperative ",
                        "chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "timing",
                    "expected_value": "preoperative"
                }
            ]
        },
        {
            "line": "* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability to communicate",
                        "coma"
                    ],
                    "criterion": "coma",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Inability to communicate",
                        "profound dementia"
                    ],
                    "criterion": "profound dementia",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Inability to communicate",
                        "language barrier"
                    ],
                    "criterion": "language barrier",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score >= 3);",
            "criterions": [
                {
                    "exact_snippets": [
                        "Preoperative obstructive sleep apnea"
                    ],
                    "criterion": "obstructive sleep apnea",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "previously diagnosed as obstructive sleep apnea"
                    ],
                    "criterion": "obstructive sleep apnea",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "STOP-Bang score >= 3"
                    ],
                    "criterion": "STOP-Bang score",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Brain trauma or neurosurgery;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Brain trauma"
                    ],
                    "criterion": "brain trauma",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "neurosurgery"
                    ],
                    "criterion": "neurosurgery",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "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",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": "<",
                        "value": 30
                    }
                },
                {
                    "exact_snippets": [
                        "sick sinus syndrome"
                    ],
                    "criterion": "sick sinus syndrome",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "severe sinus bradycardia (< 50 beats per minute)"
                    ],
                    "criterion": "sinus bradycardia",
                    "requirement_type": "severity",
                    "expected_value": {
                        "operator": "<",
                        "value": 50
                    }
                },
                {
                    "exact_snippets": [
                        "second-degree or above atrioventricular block without pacemaker"
                    ],
                    "criterion": "atrioventricular block",
                    "requirement_type": "severity",
                    "expected_value": "second-degree or above"
                },
                {
                    "exact_snippets": [
                        "second-degree or above atrioventricular block without pacemaker"
                    ],
                    "criterion": "pacemaker",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* ASA classification >= IV.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ASA classification >= IV"
                    ],
                    "criterion": "ASA classification",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Preoperative history of schizophrenia"
                    ],
                    "criterion": "schizophrenia",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Preoperative history of epilepsy"
                    ],
                    "criterion": "epilepsy",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Preoperative history of parkinsonism"
                    ],
                    "criterion": "parkinsonism",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Preoperative history of myasthenia gravis"
                    ],
                    "criterion": "myasthenia gravis",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "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_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "Severe renal dysfunction",
                        "requirement of renal replacement therapy before surgery"
                    ],
                    "criterion": "renal dysfunction",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}