Re-craniotomy and Complications After Elective Neurosurgery

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms; Brain Cancer; Brain Tumor; Brain Metastases
• Intervention / Treatment: Drug: Propofol

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 Type: Observational
• Enrollment (Actual): 439

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The adult patients who were scheduled for craniotomy to remove tumor

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no complication; the patients who did not develop any kind of complication and no re-craniotomy	Drug: Propofol; intraoperative factors; Other Names: surgical duration; operation; blood loss; blood used; fluid volume administration
with complication (s); the patients who developed at least one of non-neurological complication or required re-craniotomy	Drug: Propofol; intraoperative factors; Other Names: surgical duration; operation; blood loss; blood used; fluid volume administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-craniotomy	number of participants who required re-craniotomy assessed by the neurosurgeon	the first 24 hours
predictive factors of re-craniotomy	types of perioperative factors to predict the occurrence of re-craniotomy	the first 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Collaborators: Yodying Punjasawadwong; Prangmalee Leucharussamee; Ananchanok Saringkarinkul; Patipan Krungsri

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: neurosurgery; brain tumors; re-craniotomy; major non-neurological complications
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: ANE-2561-05961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No