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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04314674
Study type Interventional
Source Istanbul University
Contact Eren F Akcil
Phone 00905327992399
Email erenfat@yahoo.com
Status Not yet recruiting
Phase N/A
Start date April 2020
Completion date December 2022

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