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

Not Applicable

• Conditions: Brain Tumor - Metastatic; Brain Tumor, Adult: Glioblastoma
• Interventions: Drug: %3 HS bolus; Drug: %3 HS infusion 20 ml/h; Drug: 20% mannitol

• Registration Number: NCT04314674
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19
• Study Start: 2020-04
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
%3 HS bolus 3 mL.kg-1	%3 HS bolus	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	%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
%20 mannitol 0,6 gr.kg-1	20% mannitol	After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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