Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: %3 HS bolus 3 mL.kg-1 After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously. |
Drug: %3 HS bolus
After head fixation %3 HS bolus 3 ml/kg will be administered
Other Names:
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Active Comparator: %3 HS infusion 20 ml/h 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
After head fixation %3 HS 20 ml/h infusion will be administered
Other Names:
|
Active Comparator: %20 mannitol 0,6 gr.kg-1 After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously. |
Drug: 20% mannitol
After head fixation %20 mannitol 0.6 ml/kg will be administered
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Elective supratentorial tumor resection
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Glioblastoma multiforme
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Metastatic tumor
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Intracranial shift >0.5 cm
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GCS>13
Exclusion Criteria:
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Renal failure
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Heart failure
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Electrolyte imbalance
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Istanbul University
Investigators
- Study Director: Yusuf Tunali, Professor of the department
Study Documents (Full-Text)
None provided.More Information
Publications
- Dostal P, Dostalova V, Schreiberova J, Tyll T, Habalova J, Cerny V, Rehak S, Cesak T. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation in patients undergoing elective intracranial tumor surgery: a randomized clinical trial. J Neurosurg Anesthesiol. 2015 Jan;27(1):51-6. doi: 10.1097/ANA.0000000000000091.
- Hernández-Palazón J, Fuentes-García D, Doménech-Asensi P, Piqueras-Pérez C, Falcón-Araña L, Burguillos-López S. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation during elective supratentorial craniotomy. Br J Neurosurg. 2016;30(1):70-5. doi: 10.3109/02688697.2015.1109061. Epub 2015 Nov 16.
- Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.
- Neuroanesthesia Cerrahpasa