Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection
NCT ID: NCT04314674
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2020-04-30
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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%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.
%3 HS bolus
After head fixation %3 HS bolus 3 ml/kg will be administered
%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
%3 HS infusion 20 ml/h
After head fixation %3 HS 20 ml/h infusion will be administered
%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.
20% mannitol
After head fixation %20 mannitol 0.6 ml/kg will be administered
Interventions
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%3 HS bolus
After head fixation %3 HS bolus 3 ml/kg will be administered
%3 HS infusion 20 ml/h
After head fixation %3 HS 20 ml/h infusion will be administered
20% mannitol
After head fixation %20 mannitol 0.6 ml/kg will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glioblastoma multiforme
* Metastatic tumor
* Intracranial shift \>0.5 cm
* GCS\>13
Exclusion Criteria
* Heart failure
* Electrolyte imbalance
18 Years
70 Years
ALL
Yes
Sponsors
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Istanbul University
OTHER
Responsible Party
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Eren Fatma Akcil
Associate Professor
Principal Investigators
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Yusuf Tunali
Role: STUDY_DIRECTOR
Professor of the department
Central Contacts
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References
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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.
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.
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.
Other Identifiers
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Neuroanesthesia Cerrahpasa
Identifier Type: -
Identifier Source: org_study_id
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