[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurosurgical-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurosurgical-patients":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100571990","an-analgesia-first-strategy-without-hypnotic-sedatives-in-adult-patients-admitted-to-the-intensive-care-unit-after-neurosurgical-craniotomy-100571990",false,"NCT06727435","an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy","Feasibility and Safety of an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy: a Single-arm, Single-centre Exploratory Prospective Study","Inclusion criteria\n\n1. Age 18-85 years;\n2. Admission to the ICU after neurosurgical craniotomy;\n3. Anticipated ICU stay greater than 24 hours according to the treating team at ICU admission or screening;\n4. The Richmond Agitation-Sedation Scale (RASS) score ≥ +1, indicating restlessness or agitation requiring clinical management;\n5. RASS, the Critical Care Pain Observation Tool (CPOT), and neurological status can be assessed reliably enough for protocol monitoring.\n\nExclusion criteria\n\n1. Need for deep sedation or therapeutic coma, including (partial pressure of oxygen(PaO2)\u002Ffraction of inspired oxygen(FiO2): PaO2\u002FFiO2≤100 mmHg, neuromuscular blockade requiring unconsciousness, status epilepticus, mandatory immobility for surgical or procedural safety, severe traumatic brain injury and intracranial hypertension, therapeutic hypothermia and any clinical condition requiring RASS \\\u003C -2) \\[15, 16\\];\n2. Medullary lesion, brainstem condition, or other disorder associated with impaired respiratory drive in which opioid analgesia is judged unsafe by the treating physician \\[17\\];\n3. Inability to assess the RASS score or neurological status because of coma, severe aphasia, status epilepticus, severe cognitive dysfunction, schizophrenia, mania, or aother psychiatric or neurological condition that precludes reliable assessment.;\n4. Use of sedatives or opioid analgesics ≥ 1 week before enrollment;\n5. Expected ICU stay time less than or equal to 24 hours;\n6. Delirium, alcohol withdrawal, active severe psychiatric illness, or ongoing antipsychotic therapy before enrolment;\n7. Severe hepatic dysfunction (Child-Pugh grade C);\n8. Renal failure requiring renal replacement therapy;\n9. Need for major surgery during the ICU stay, except short bedside or minor procedures, such as lumbar puncture or ventricular drainage, etc.);\n10. Known allergy or contraindication to remifentanil, morphine, midazolam, propofol, or other protocol medications;\n11. Pregnancy or lactation;\n12. Participation in another interventional clinical trial that could interfere with the study intervention or outcomes.;\n13. Patient or legally authorized representative unwilling to participate;\n14. Investigator judgment that inclusion is inappropriate because of a specific safety concern that is documented in the screening record.","ALL","18 Years","85 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"NA","Analgesia and sedation are core components of intensive care unit (ICU) care. They are used to relieve pain and anxiety, prevent harmful physiological stress responses, improve tolerance of invasive devices and mechanical ventilation, and reduce noxious stimulation. Contemporary ICU practice has moved away from deep continuous sedation toward analgesia-first care, lighter sedation targets, delirium prevention, early mobilization, and patient-centred comfort strategies.\n\nPatients admitted to the ICU after neurosurgical craniotomy pose a specific challenge. Postoperative agitation after intracranial surgery may lead to unplanned extubation, catheter or drain removal, injury, hypertension, coughing, increased sympathetic activation, and potentially adverse neurological consequences. The incidence of agitation after elective intracranial operations was 29%, which was higher than that previously observed in other surgical populations. Neurosurgical patients may be more vulnerable to stress caused by agitation, due to longer anesthesia duration, delayed extubation and pain and post-craniotomy frontal pneumocephalus. Brain lesions and intracranial manipulations in neurosurgical patients might affect the brain regions which involves cognition and emotion, and are assumed to influence postoperative cognition. At the same time, excessive hypnotic sedation may obscure level of consciousness, pupillary and focal neurological examinations, early seizures, intracranial hypertension, or surgical complications. Previous neurosurgical studies have reported postoperative agitation and delirium after craniotomy were not rare, and risk factors including longer anesthesia duration, delayed extubation, pain, and postoperative pneumocephalus have been reported.\n\nHowever, the investigations of analgesia and sedation in neurosurgical populations have been inadequate. Most of the researches about analgesia and sedation in general ICU were excluded the neurosurgical patients. These patients are special for its cruciality of evaluating the consciousness and neurological signs examination. The analgesia and sedation management is difficult and complex. Several general ICU studies support interest in minimizing routine hypnotic sedation. In a single-centre randomized trial, a protocol of no sedation with morphine boluses increased ventilator-free days and shortened ICU and hospital stay compared with sedation and daily interruption, although agitated delirium was more frequent. In the larger multicentre NONSEDA trial, mortality at 90 days did not differ significantly between nonsedation and light sedation with daily interruption, and many patients in the nonsedation group still required sedatives during ICU stay, most commonly because of delirium. Related NONSEDA substudies have also emphasized that the effects of nonsedation on physical function and cognition require dedicated evaluation.\n\nThese findings cannot be directly transferred to post-craniotomy neurocritical care. Reviews, consensus statements and observational studies in neurocritical care emphasize with brain-injured patients have unique sedation indications, including control of intracranial pressure, seizures, cerebral oxygen consumption, ventilator synchrony, and severe agitation. Observational data from brain-injury ICUs show wide variation in sedative and analgesic practice and support structured use of sedation and pain scales. Expert consensus also supports administering analgesics before sedatives when clinically appropriate, but acknowledges the limited high-quality evidence in this population. Therefore, an analgesia-first strategy without routine hypnotic sedatives should be evaluated cautiously with explicit neurological safety monitoring and rescue criteria.\n\nRemifentanil is a short-acting opioid with rapid onset and offset because it is metabolized by non-specific blood and tissue esterases. These pharmacological features make it suitable for titrated analgesia when repeated neurological assessment is needed. We therefore designed this single-arm exploratory study to estimate the feasibility and safety of a remifentanil-based analgesia-first strategy without routine hypnotic sedatives in selected adult patients admitted to ICU after neurosurgical craniotomy.",[27,28],"Craniotomy","Neurosurgical Patients",[30,31,32,33,34],"neurosurgical patients","analgesia-first","remifentanil","analgesia and sedation","neurosurgical craniotomy","NOT_YET_RECRUITING","2026-05-23",{"date":38,"type":39},"2026-05-28","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2028-08-31",{"name":45,"class":46},"Beijing Tiantan Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100560972","comparative-performance-of-general-purpose-models-100560972","NCT06584097","COMparative Performance of General Purpose Models","COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit","Inclusion Criteria:\n\n* Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \\> 12 hours • Requirement for an arterial line\n\nExclusion Criteria:\n\n* Pregnancy\n\n  * Known sensitivity or allergy to propofol or remifentanil\n  * Patient participating in research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.\n  * Age \\\u003C 18 years old\n  * Patients subjected to infusion of propofol and\u002For remifentanil not delivered through TCI pumps before the inclusion\n  * Patients exposed to other sedatives (benzodiazepines, volatile anesthetics, quetiapine) before the inclusion",{"count":56,"type":21},42,"OBSERVATIONAL","To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.",[28],[61,62,63,64],"Neuroanesthesia","total intravenous anesthesia","target controlled infusion","PKPD modelling","RECRUITING","2026-02-10",{"date":68,"type":39},"2026-02-12",{"date":70,"type":39},"2024-10-02",{"date":72,"type":21},"2026-12-31",{"name":74,"class":46},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"]