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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02537106
Enrollment
100
Registered
2015-09-01
Start date
2015-09-30
Completion date
2019-05-31
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors

Keywords

Brain Tumors, Microcirculation, Osmotherapy, Hypertonic NaCl, Natremia

Brief summary

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

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.

Interventions

PROCEDURE1.5% 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.

PROCEDURE3% 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.

Sponsors

University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in brain microcirculationfrom dura opening till the end of tumor resectionmeasurement by SDF probe MicroVision

Secondary

MeasureTime frameDescription
Changes in natremia1 hour after hypertonic NaCl infusionmmol/l
Changes in osmolarity1 hour after hypertonic NaCl infusionmosm/l
Concentration of natrium in cerebrospinal fluidafter dura openingmmol/l

Other

MeasureTime frameDescription
Changes in diuresisat the time of extubationml/hour

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026