Re-craniotomy and Complications After Elective Neurosurgery

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910556
• Other study ID #: ANE-2561-05961
• Status: Completed
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Metastases
• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• Propofol
intraoperative factors

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Chiang Mai University	Ananchanok Saringkarinkul, Patipan Krungsri, Prangmalee Leucharussamee, Yodying Punjasawadwong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	re-craniotomy	number of participants who required re-craniotomy assessed by the neurosurgeon	the first 24 hours
Primary	predictive factors of re-craniotomy	types of perioperative factors to predict the occurrence of re-craniotomy	the first 24 hours
Secondary	incidence of major non-neurological complications	number of participants who develop any major systemic complications	the first 24 hours
Secondary	predictive factors of major non-neurological complications	types of predictive factors to predict the occurrence of major non-neurological complications	the first 24 hours