Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Propofol
- Conditions
- Brain Tumor
- Sponsor
- Chiang Mai University
- Enrollment
- 439
- Primary Endpoint
- re-craniotomy
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Pathomporn Pin on, M.D.
Assistant Professor
Chiang Mai University
Eligibility Criteria
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
Arms & Interventions
no complication
the patients who did not develop any kind of complication and no re-craniotomy
Intervention: Propofol
with complication (s)
the patients who developed at least one of non-neurological complication or required re-craniotomy
Intervention: Propofol
Outcomes
Primary Outcomes
re-craniotomy
Time Frame: the first 24 hours
number of participants who required re-craniotomy assessed by the neurosurgeon
predictive factors of re-craniotomy
Time Frame: the first 24 hours
types of perioperative factors to predict the occurrence of re-craniotomy
Secondary Outcomes
- incidence of major non-neurological complications(the first 24 hours)
- predictive factors of major non-neurological complications(the first 24 hours)