Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection

Study Overview
=================
Brief Summary
-----------------
Hyperosmotic agents are used to decrease intracranial pressure. The aim of the study is to compare the effects of continuous 3% hypertonic saline (HS), bolus HS and 20% mannitol on intraoperative brain relaxation in patients with raised intracranial pressure during surgery for supratentorial tumors.

Detailed Description
-----------------
After obtaining approval from the ethics committee and informed consent, a total of 90 patients aged 18-70 years, conscious (GCS>13) and American Society of Anesthesiologists (ASA) class I-III, who had intracranial shift >0.5 cm or glioblastoma multiforme or metastatic tumor and who were scheduled for supratentorial mass resection under elective conditions, will be included in the present prospective, randomized, double-blind and placebo-controlled study. Patients with heart failure, kidney insufficiency, diabetes insipidus, electrolyte imbalance and who are unconscious will be excluded from the study. The patients will randomized into 3 groups: Group 1: %3 HS bolus 3 mL.kg-1 Group 2: %3 HS infusion 20 ml/h Group 3: %20 mannitol 0,6 gr.kg-1 After head fixation, all patients will be administered with HS or mannitol (over 20 minutes). Arterial blood gas (ABG) analysis (Cobas b 221 blood gas analyzer, Roche®, Basel, Switzerland) will be made at 30 minute,2,4,6,8. hours. Blood sodium, potassium, chlorine, base excess, lactate levels and blood osmolarity will be recorded in each time intervals. The brain relaxation scale will be recorded at the time of dura opening.

Official Title
-----------------
Comparison of Continuous Infusion of 3% Hypertonic Saline, Bolus of 3% Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumor Resection: A Prospective, Randomized, Clinical Study

Conditions
-----------------
Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma

Intervention / Treatment
-----------------
* Drug: %3 HS bolus
* Drug: %3 HS infusion 20 ml/h
* Drug: 20% mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective supratentorial tumor resection Glioblastoma multiforme Metastatic tumor Intracranial shift >0.5 cm GCS>13 Exclusion Criteria: Renal failure Heart failure Electrolyte imbalance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: %3 HS bolus 3 mL.kg-1 Group 2: %3 HS infusion 20 ml/h Group 3: %20 mannitol 0,6 gr.kg-1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: %3 HS bolus 3 mL.kg-1<br>After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously. | Drug: %3 HS bolus<br>* After head fixation %3 HS bolus 3 ml/kg will be administered<br>* Other names: Group 1;|
| Active Comparator: %3 HS infusion 20 ml/h<br>After the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation | Drug: %3 HS infusion 20 ml/h<br>* After head fixation %3 HS 20 ml/h infusion will be administered<br>* Other names: Group 2;|
| Active Comparator: %20 mannitol 0,6 gr.kg-1<br>After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously. | Drug: 20% mannitol<br>* After head fixation %20 mannitol 0.6 ml/kg will be administered<br>* Other names: Group 3;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain relaxation score | Brain relaxation score 1: Brain is under the dura, 2: Brain is in the dura level, 3:Brain is above the dura, 4: There is no pulsation in the brain | 1. min before dura closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium level | Blood sodium levels obtained from arterial blood gases analysis | Baseline and after the drug administration 30. min, 2,4,6,8. hours | 
| Potassium level | Blood potassium levels obtained from arterial blood gases analysis | Baseline and after the drug administration 30. min, 2,4,6,8. hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertonic saline, mannitol, supratentorial brain tumor