Re-craniotomy and Complications After Elective Neurosurgery

Study Overview
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Brief Summary
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This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.

Detailed Description
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Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation. Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation. Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.

Official Title
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Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study

Conditions
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Brain Tumor, Brain Metastases, Brain Cancer, Brain Neoplasms

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled for elective craniotomy during 2017-2019 Patients who are planned for general anesthesia Patients have read the study information and signed in the consent form Exclusion Criteria: Patients who are unable to understand and sign in the consent form Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no complication<br>the patients who did not develop any kind of complication and no re-craniotomy | Drug: Propofol<br>* intraoperative factors<br>* Other names: fluid volume administration;|
| with complication (s)<br>the patients who developed at least one of non-neurological complication or required re-craniotomy | Drug: Propofol<br>* intraoperative factors<br>* Other names: fluid volume administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-craniotomy | number of participants who required re-craniotomy assessed by the neurosurgeon | the first 24 hours | 
| predictive factors of re-craniotomy | types of perioperative factors to predict the occurrence of re-craniotomy | the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of major non-neurological complications | number of participants who develop any major systemic complications | the first 24 hours | 
| predictive factors of major non-neurological complications | types of predictive factors to predict the occurrence of major non-neurological complications | the first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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re-craniotomy, major non-neurological complications, neurosurgery, brain tumors