{
"info": {
"nct_id": "NCT02713087",
"official_title": "Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors",
"inclusion_criteria": "* Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images)\n* ASA (American Society of Anesthesiologist) status 1-3 (27)\n* Written informed consent from participating patients\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Age younger than 18 yrs. or older than 75 yrs.\n* Pregnancy or nursing (negative pregnancy blood test)\n* History of allergic reactions to phenylephrine or ephedrine\n* eGFR < 60ml/min/1.73m2",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images)",
"criterions": [
{
"exact_snippets": [
"supine-positioned elective craniotomy"
],
"criterion": "craniotomy",
"requirement_type": "position",
"expected_value": "supine"
},
{
"exact_snippets": [
"elective craniotomy"
],
"criterion": "craniotomy",
"requirement_type": "type",
"expected_value": "elective"
},
{
"exact_snippets": [
"supratentorial malignant and non-malignant brain tumors"
],
"criterion": "brain tumor",
"requirement_type": "location",
"expected_value": "supratentorial"
},
{
"exact_snippets": [
"malignant and non-malignant brain tumors"
],
"criterion": "brain tumor",
"requirement_type": "malignancy",
"expected_value": [
"malignant",
"non-malignant"
]
},
{
"exact_snippets": [
"brain tumors 3 cm or larger"
],
"criterion": "brain tumor",
"requirement_type": "size",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3
}
]
}
}
]
},
{
"line": "* ASA (American Society of Anesthesiologist) status 1-3 (27)",
"criterions": [
{
"exact_snippets": [
"ASA (American Society of Anesthesiologist) status 1-3"
],
"criterion": "ASA status",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1
},
{
"operator": "<=",
"value": 3
}
]
}
}
]
},
{
"line": "* Written informed consent from participating patients",
"criterions": [
{
"exact_snippets": [
"Written informed consent"
],
"criterion": "informed consent",
"requirement_type": "form",
"expected_value": "written"
},
{
"exact_snippets": [
"participating patients"
],
"criterion": "patient participation",
"requirement_type": "status",
"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
}
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 75 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Age younger than 18 yrs. or older than 75 yrs.",
"criterions": [
{
"exact_snippets": [
"Age younger than 18 yrs."
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
},
{
"exact_snippets": [
"older than 75 yrs."
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 75
}
]
}
}
]
},
{
"line": "* Pregnancy or nursing (negative pregnancy blood test)",
"criterions": [
{
"exact_snippets": [
"Pregnancy"
],
"criterion": "pregnancy",
"requirement_type": "presence",
"expected_value": false
},
{
"exact_snippets": [
"nursing"
],
"criterion": "nursing",
"requirement_type": "presence",
"expected_value": false
},
{
"exact_snippets": [
"negative pregnancy blood test"
],
"criterion": "pregnancy blood test",
"requirement_type": "result",
"expected_value": "negative"
}
]
},
{
"line": "* eGFR < 60ml/min/1.73m2",
"criterions": [
{
"exact_snippets": [
"eGFR < 60ml/min/1.73m2"
],
"criterion": "eGFR",
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 60
}
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* History of allergic reactions to phenylephrine or ephedrine",
"criterions": [
{
"exact_snippets": [
"History of allergic reactions to phenylephrine"
],
"criterion": "allergic reactions",
"requirement_type": "history",
"expected_value": "phenylephrine"
},
{
"exact_snippets": [
"History of allergic reactions to ephedrine"
],
"criterion": "allergic reactions",
"requirement_type": "history",
"expected_value": "ephedrine"
}
]
}
],
"failed_miscellaneous": []
}