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Re-craniotomy and Complications After Elective Neurosurgery

C

Chiang Mai University

Status

Completed

Conditions

Brain Metastases
Brain Tumor
Brain Cancer
Brain Neoplasms

Treatments

Drug: Propofol

Study type

Observational

Funder types

Other

Identifiers

NCT03910556
ANE-2561-05961

Details and patient eligibility

About

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.

Full 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.

Enrollment

439 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

439 participants in 2 patient groups

no complication
Description:
the patients who did not develop any kind of complication and no re-craniotomy
Treatment:
Drug: Propofol
with complication (s)
Description:
the patients who developed at least one of non-neurological complication or required re-craniotomy
Treatment:
Drug: Propofol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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