Clinical trial NCT02537106: A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumors
Keywords: Brain Tumors
Microcirculation
Osmotherapy
Hypertonic NaCl
Natremia
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in brain microcirculation
timeFrame: from dura opening till the end of tumor resection
Secondary outcomes:
measure: Changes in natremia
timeFrame: 1 hour after hypertonic NaCl infusion
measure: Changes in natremia
timeFrame: 5 min after the end of surgery
measure: Changes in osmolarity
timeFrame: 1 hour after hypertonic NaCl infusion
measure: Changes in osmolarity
timeFrame: 5 min after the end of surgery
measure: Concentration of natrium in cerebrospinal fluid
timeFrame: after dura opening
Other outcomes:
measure: Changes in diuresis
timeFrame: at the time of extubation
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vlasta Dostalova, MD.
role: PRINCIPAL_INVESTIGATOR
References: