Re-craniotomy and Complications After Elective Neurosurgery

Completed

• Conditions: Brain Neoplasms; Brain Tumor; Brain Cancer; Brain Metastases
• Interventions: Drug: Propofol

• Registration Number: NCT03910556
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-04
• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
re-craniotomy	the first 24 hours	number of participants who required re-craniotomy assessed by the neurosurgeon
predictive factors of re-craniotomy	the first 24 hours	types of perioperative factors to predict the occurrence of re-craniotomy

Secondary Outcome Measures

Name	Time	Method
incidence of major non-neurological complications	the first 24 hours	number of participants who develop any major systemic complications
predictive factors of major non-neurological complications	the first 24 hours	types of predictive factors to predict the occurrence of major non-neurological complications