{
    "info": {
        "nct_id": "NCT03040024",
        "official_title": "A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients",
        "inclusion_criteria": "* Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia\n* Competent to provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Emergency surgery\n* Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia)\n* Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement\n* Poor health literacy\n* Allergy, or have experienced any drug reaction to ketamine\n* Pregnant or lactating\n* Currently in active alcohol withdrawal\n* Taking buprenorphine for chronic pain",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current diagnosis of otolaryngeal cancer"
                    ],
                    "criterion": "otolaryngeal cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "undergoing surgery"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "undergoing",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "general anesthesia"
                    ],
                    "criterion": "anesthesia",
                    "requirement_type": "type",
                    "expected_value": "general"
                }
            ]
        },
        {
            "line": "* Competent to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "Competent to provide informed consent"
                    ],
                    "criterion": "competence",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Emergency surgery",
            "criterions": [
                {
                    "exact_snippets": [
                        "Emergency surgery"
                    ],
                    "criterion": "emergency surgery",
                    "requirement_type": "necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general anesthesia)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Monitored Anesthesia Care"
                    ],
                    "criterion": "anesthesia care",
                    "requirement_type": "type",
                    "expected_value": "Monitored"
                },
                {
                    "exact_snippets": [
                        "regional anesthesia alone"
                    ],
                    "criterion": "anesthesia",
                    "requirement_type": "type",
                    "expected_value": "regional"
                },
                {
                    "exact_snippets": [
                        "without plans for general anesthesia"
                    ],
                    "criterion": "general anesthesia",
                    "requirement_type": "plans",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Poor health literacy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Poor health literacy"
                    ],
                    "criterion": "health literacy",
                    "requirement_type": "quality",
                    "expected_value": "poor"
                }
            ]
        },
        {
            "line": "* Allergy, or have experienced any drug reaction to ketamine",
            "criterions": [
                {
                    "exact_snippets": [
                        "Allergy"
                    ],
                    "criterion": "allergy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "experienced any drug reaction to ketamine"
                    ],
                    "criterion": "drug reaction to ketamine",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Currently in active alcohol withdrawal",
            "criterions": [
                {
                    "exact_snippets": [
                        "Currently in active alcohol withdrawal"
                    ],
                    "criterion": "alcohol withdrawal",
                    "requirement_type": "status",
                    "expected_value": "active"
                }
            ]
        },
        {
            "line": "* Taking buprenorphine for chronic pain",
            "criterions": [
                {
                    "exact_snippets": [
                        "Taking buprenorphine"
                    ],
                    "criterion": "buprenorphine",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "chronic pain"
                    ],
                    "criterion": "chronic pain",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor placement",
            "criterions": [
                {
                    "exact_snippets": [
                        "Surgery involving the eye"
                    ],
                    "criterion": "eye",
                    "requirement_type": "surgery involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Surgery involving the eyebrow"
                    ],
                    "criterion": "eyebrow",
                    "requirement_type": "surgery involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Surgery involving the forehead"
                    ],
                    "criterion": "forehead",
                    "requirement_type": "surgery involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Surgery involving the frontal scalp"
                    ],
                    "criterion": "frontal scalp",
                    "requirement_type": "surgery involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "near the sensor placement"
                    ],
                    "criterion": "sensor placement",
                    "requirement_type": "proximity",
                    "expected_value": "near"
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}