Clinical trial NCT03910556: Re-craniotomy and Complications After Elective Neurosurgery
Official title: Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Brain Metastases
Brain Cancer
Brain Neoplasms
Keywords: re-craniotomy
major non-neurological complications
neurosurgery
brain tumors
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: Yodying Punjasawadwong
name: Prangmalee Leucharussamee
name: Ananchanok Saringkarinkul
name: Patipan Krungsri
First posted: 2019-04-10
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The adult patients who were scheduled for craniotomy to remove tumor

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.

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

Primary outcomes:
measure: re-craniotomy
timeFrame: the first 24 hours
measure: predictive factors of re-craniotomy
timeFrame: the first 24 hours
Secondary outcomes:
measure: incidence of major non-neurological complications
timeFrame: the first 24 hours
measure: predictive factors of major non-neurological complications
timeFrame: the first 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Chiang Mai University
name: Pathomporn Pin-on, MD
role: PRINCIPAL_INVESTIGATOR
References: