Effects of Intraoperative GDFT on the Postoperative Brain Edema

Beijing Tiantan Hospital480 enrolled

Overview

Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

480

Conditions

Fluid Therapy Brain Edema Brain Tumor

Interventions

Target parameter will be titrated with fluid bolus, and thus individual amount varied depending on the parameter value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.

traditional fluid therapyOTHER

Fluid therapy will be done without goal directed. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preoperative brain image indicating high-grade glioma (HGG), verified by postoperative histology of the World Health Organization (WHO) as grade III or IV tumors. 2. Age 18-65 years, and American Society of Anaesthesiologists (ASA) physical status I to III. 3. Signed informed consent. Exclusion Criteria: 1. Renal insufficiency or the creatinine clearance is \< 30 mL/kg. 2. Heart disease, New York Heart Association Functional Classification (NYHA) class II or higher heart failure, or if their cardiac ejection fraction is \< 20%. 3. Chronic obstructive pulmonary disease. 4. Extensive peripheral arterial occlusive disease. 5. Coagulopathy. 6. Surgery in the prone position. 7. Recurrent carcinoma or tumor in the brain ventricular. 8. Body Mass Index \<18.5 kg·m-2 or \>30.0 kg·m-2. 9. Awake craniotomy.

Outcomes

Primary Outcomes

Quantitative analysis of brain edema

Postoperative brain edema is defined as edema surrounding the surgical resection cavity, which will be evaluated through CT images.Image evaluators will manually delineate region of interest (ROI) and operative cavity on each slice. The area will be calculated automatically by PACS system. The total volume will be acquired by multiplying area and slice thickness. The volume of edema will be calculated by the totoal volume of edema plus cavity minus the volume of cavity.

Time frame: Within 24 hours postoperatively

Secondary Outcomes

The incidence of delirium

Delirium was assessed twice daily (between 8-10 am and between 6-8 pm) with the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-minute Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessments, combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments were only conducted in patients with RASS sedation score exceeding -4.

Time frame: During the first 3 postoperative days