Brain Tumor, Adult: Glioblastoma, Brain Tumor - Metastatic
Conditions
Keywords
hypertonic saline, mannitol, supratentorial brain tumor
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.
Interventions
DRUG%3 HS bolus
After head fixation %3 HS bolus 3 ml/kg will be administered
DRUG%3 HS infusion 20 ml/h
After head fixation %3 HS 20 ml/h infusion will be administered
DRUG20% mannitol
After head fixation %20 mannitol 0.6 ml/kg will be administered
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
All the patients, the anesthesiologist who will evaluate the postoperative cranial CT will be blind to study group
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain relaxation score | 1. min before dura closure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sodium level | Baseline and after the drug administration 30. min, 2,4,6,8. hours | Blood sodium levels obtained from arterial blood gases analysis |
| Potassium level | Baseline and after the drug administration 30. min, 2,4,6,8. hours | Blood potassium levels obtained from arterial blood gases analysis |
Contacts
Primary ContactEren F Akcil
Outcome results
None listed