Clinical trial NCT04314674: Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor - Metastatic
Brain Tumor, Adult: Glioblastoma
Keywords: hypertonic saline, mannitol, supratentorial brain tumor
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brain relaxation score
timeFrame: 1. min before dura closure
Secondary outcomes:
measure: Sodium level
timeFrame: Baseline and after the drug administration 30. min, 2,4,6,8. hours
measure: Potassium level
timeFrame: Baseline and after the drug administration 30. min, 2,4,6,8. hours
Other outcomes:
Locations:
Study officials:
affiliation: Professor of the department
name: Yusuf Tunali
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.