A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation

Study Overview
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Brief Summary
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Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and natriuresis is less pronounced.

Detailed Description
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All the patients meeting the study criteria will be randomized into two groups. After standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic NaCl 5 ml/kg/BW during 30 min, group A 1.5% NaCl, group B 3% NaCl. Corticosteroids will be administered as usually. After dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of SDF probe in the area of the healthy brain, and of perifocal oedema. Both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. Laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after NaCl infusion and at the end of surgery. Concentration of natrium will be examined in CSF after dura opening. Anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.

Official Title
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A Comparison of the Effect of 1.5% Versus 3% NaCl on Brain Relaxation and Microcirculation During the Supratentorial Brain Tumor Surgery, and Natremia and Osmolarity in Postoperative Period

Conditions
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Brain Tumors

Intervention / Treatment
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* Procedure: 1.5% NaCl
* Procedure: 3% NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peripheral supratentorial brain tumors or metastasis indication for osmotherapy ASA status I-III Exclusion Criteria: reoperation osmotherapy prior to surgery preoperative natremia less than 135 mmol/l and more than 140 mmol/l GCS less than 14 obstructive hydrocephalus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.5% NaCl<br>After standardized induction to general anesthesia group A patients will be given the infusion of hyperosmotic 1.5% NaCl 5 ml/kg/BW during 15 min. | Procedure: 1.5% NaCl<br>* After the infusion of 1.5% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.<br>|
| Experimental: 3% NaCl<br>After standardized induction to general anesthesia group B patients will be given the infusion of hyperosmotic 3% NaCl 5 ml/kg/BW during 15 min. | Procedure: 3% NaCl<br>* After the infusion of 3% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in brain microcirculation | measurement by SDF probe MicroVision | from dura opening till the end of tumor resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in natremia | mmol/l | 1 hour after hypertonic NaCl infusion | 
| Changes in natremia | mmol/l | 5 min after the end of surgery | 
| Changes in osmolarity | mosm/l | 1 hour after hypertonic NaCl infusion | 
| Changes in osmolarity | mosm/l | 5 min after the end of surgery | 
| Concentration of natrium in cerebrospinal fluid | mmol/l | after dura opening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Tumors, Microcirculation, Osmotherapy, Hypertonic NaCl, Natremia