Brain Tumor, Craniotomy
Conditions
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.
Interventions
Pulse pressure variation obtained from invasive blood pressure waveform
PROCEDURETraditional 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.
PROCEDUREBrain tumor excision
Brain tumor excision under general anesthesia
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| serum lactate | one hour postoperatively | in mmol per decilitre |
| Hemoglobin concentration | one hour postoperatively | in grams per decilitre |
| prothrombin concentration | one hour postoperatively | in percent |
| arterial blood gases | one hour postoperatively | partial pressure of oxygen and carbon dioxide |
| Urine output | intraoperatively | Litres |
| heart rate | intraoperatively | in beat per minute |
| number of episodes of hypotension | intraoperatively | number of times where the blood pressure decreased by 25% of baseline |
| volume of intraoperative fluid requirements | intraoperatively | in litres |
Countries
Egypt
Outcome results
None listed