Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection

Brain Tumor - Metastatic Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04314674
• Other study ID #: Neuroanesthesia Cerrahpasa
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Istanbul University
• Contact: Eren F Akcil
• Phone: 00905327992399
• Email: erenfat[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor - Metastatic
• Brain Tumor, Adult: Glioblastoma
• Glioblastoma
• Neoplasms
• Supratentorial Neoplasms

Intervention

Drug:
• %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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Sodium level	Blood sodium levels obtained from arterial blood gases analysis	Baseline and after the drug administration 30. min, 2,4,6,8. hours
Secondary	Potassium level	Blood potassium levels obtained from arterial blood gases analysis	Baseline and after the drug administration 30. min, 2,4,6,8. hours