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

University Hospital Hradec Kralove

Status: Completed

Conditions: Brain Tumors

Treatments: Procedure: 3% NaCl; Procedure: 1.5% NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT02537106

201508-S23P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

1.5% NaCl

Experimental group

Description:

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.

Treatment:

Procedure: 1.5% NaCl

3% NaCl

Experimental group

Description:

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.

Treatment:

Procedure: 3% NaCl