NCT03033706

Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Tumor
• Craniotomy

Interventions

Type	Name	Description
PROCEDURE	Pulse pressure variation guided fluid therapy	Pulse pressure variation obtained from invasive blood pressure waveform
PROCEDURE	Traditional fluid therapy	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	Brain tumor excision	Brain tumor excision under general anesthesia

Timeline

• Start date: 2017-03-25
• Primary completion: 2018-01-25
• Completion: 2018-01-30
• First posted: 2017-01-27
• Last updated: 2018-11-23

Locations

1 site across 1 country: Egypt