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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-05-31

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.

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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.

Conditions

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Brain Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1.5% NaCl

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.

Group Type EXPERIMENTAL

1.5% NaCl

Intervention Type PROCEDURE

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.

3% NaCl

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.

Group Type EXPERIMENTAL

3% NaCl

Intervention Type PROCEDURE

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.

Interventions

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1.5% NaCl

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.

Intervention Type PROCEDURE

3% NaCl

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No