Re-craniotomy and Complications After Elective Neurosurgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-02-28

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.

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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.

Conditions

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Brain Tumor Brain Metastases Brain Cancer Brain Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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no complication

the patients who did not develop any kind of complication and no re-craniotomy

Propofol

Intervention Type DRUG

intraoperative factors

with complication (s)

the patients who developed at least one of non-neurological complication or required re-craniotomy

Propofol

Intervention Type DRUG

intraoperative factors

Interventions

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Propofol

intraoperative factors

Intervention Type DRUG

Other Intervention Names

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surgical duration operation blood loss blood used fluid volume administration

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No