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Re-craniotomy and Complications After Elective Neurosurgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03910556
Enrollment
439
Registered
2019-04-10
Start date
2017-01-31
Completion date
2019-02-28
Last updated
2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Brain Metastases, Brain Neoplasms, Brain Tumor

Keywords

re-craniotomy, major non-neurological complications, neurosurgery, brain tumors

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.

Interventions

DRUGPropofol

intraoperative factors

Sponsors

Yodying Punjasawadwong
CollaboratorUNKNOWN
Prangmalee Leucharussamee
CollaboratorUNKNOWN
Ananchanok Saringkarinkul
CollaboratorUNKNOWN
Patipan Krungsri
CollaboratorUNKNOWN
Chiang Mai University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
re-craniotomythe first 24 hoursnumber of participants who required re-craniotomy assessed by the neurosurgeon
predictive factors of re-craniotomythe first 24 hourstypes of perioperative factors to predict the occurrence of re-craniotomy

Secondary

MeasureTime frameDescription
incidence of major non-neurological complicationsthe first 24 hoursnumber of participants who develop any major systemic complications
predictive factors of major non-neurological complicationsthe first 24 hourstypes of predictive factors to predict the occurrence of major non-neurological complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026