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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| %3 HS bolus 3 mL.kg-1 | Active Comparator | After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously. |
|
| %3 HS infusion 20 ml/h | Active Comparator | After the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation |
|
| %20 mannitol 0,6 gr.kg-1 | Active Comparator | After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| %3 HS bolus | Drug | After head fixation %3 HS bolus 3 ml/kg will be administered |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eren F Akcil | Contact | 00905327992399 | erenfat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yusuf Tunali | Professor of the department | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23354336 | Background | 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. | |
| 25036870 |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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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
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All the patients, the anesthesiologist who will evaluate the postoperative cranial CT will be blind to study group
| %3 HS infusion 20 ml/h | Drug | After head fixation %3 HS 20 ml/h infusion will be administered |
|
|
| 20% mannitol | Drug | After head fixation %20 mannitol 0.6 ml/kg will be administered |
|
|
| Baseline and after the drug administration 30. min, 2,4,6,8. hours |
| 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. |
| 26571037 | Background | Hernandez-Palazon J, Fuentes-Garcia D, Domenech-Asensi P, Piqueras-Perez C, Falcon-Arana L, Burguillos-Lopez 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. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |