Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Not Applicable

Completed

• Conditions: Brain Tumor; Craniotomy
• Interventions: Procedure: Pulse pressure variation guided fluid therapy; Procedure: Traditional fluid therapy; Procedure: Brain tumor excision

• Registration Number: NCT03033706
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Study Start: 2017-03-25
• Primary Completion: 2018-01-25
• Study Completion: 2018-01-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Patients scheduled for supratentorial mass excision will be enrolled in the study.

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Exclusion Criteria

• Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Brain tumor excision	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%.
Control group	Brain tumor excision	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.
Study group	Pulse pressure variation guided fluid therapy	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%.
Control group	Traditional fluid therapy	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of brain relaxation	one minute after dural puncture and one minute before dural closure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt