Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Study Overview
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Brief Summary
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Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Detailed Description
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Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics, and prolonged operative time. The role of fluid therapy in these patients is very critical, hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased intracranial tension. All these factors make fluid management in these procedures complex and challenging. Evidence on the optimum protocol for intraoperative fluid management in neurosurgical patients is still lacking. Goal-directed therapy (GDT) in the operating room is a term used to describe the use of cardiac output or similar parameters to guide intravenous fluid and inotropic therapy. Although GDT was well reported in many procedures, its benefit in neurosurgical operations is not well studied. Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in major abdominal surgery with good performance. The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures GDT might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Official Title
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Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study

Conditions
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Brain Tumor, Craniotomy

Intervention / Treatment
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* Procedure: Pulse pressure variation guided fluid therapy
* Procedure: Traditional fluid therapy
* Procedure: Brain tumor excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for supratentorial mass excision will be enrolled in the study. Exclusion Criteria: Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation guided fluid therapy): Study group will receive restricted fluid management with 1 ml/Kg/hr with concomitant PPV monitoring. PPV will be measured using invasive blood pressure monitor. Fluid bolus of 3 ml/Kg of ringer solution will be administrated whenever PPV is higher than 13%. | Procedure: Pulse pressure variation guided fluid therapy<br>* Pulse pressure variation obtained from invasive blood pressure waveform<br>Procedure: Brain tumor excision<br>* Brain tumor excision under general anesthesia<br>|
| Placebo Comparator: Control group<br>Brain tumor excision under general anesthesia. Intervention (Traditional fluid therapy): Control Group will receive standard fluid management of 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg. | Procedure: Traditional fluid therapy<br>* 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.<br>Procedure: Brain tumor excision<br>* Brain tumor excision under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of brain relaxation | A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain. | one minute after dural puncture and one minute before dural closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of intraoperative fluid requirements | in litres | intraoperatively | 
| Urine output | Litres | intraoperatively | 
| heart rate | in beat per minute | intraoperatively | 
| number of episodes of hypotension | number of times where the blood pressure decreased by 25% of baseline | intraoperatively | 
| arterial blood gases | partial pressure of oxygen and carbon dioxide | one hour postoperatively | 
| serum lactate | in mmol per decilitre | one hour postoperatively | 
| Hemoglobin concentration | in grams per decilitre | one hour postoperatively | 
| prothrombin concentration | in percent | one hour postoperatively |