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Completed

NCT Number: NCT02537106

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.5% NaCl

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

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.

Primary outcomes

  1. Changes in brain microcirculation

    Time frame: from dura opening till the end of tumor resection

    measurement by SDF probe MicroVision

Secondary outcomes

  1. Changes in natremia

    Time frame: 1 hour after hypertonic NaCl infusion

    mmol/l

  2. Changes in natremia

    Time frame: 5 min after the end of surgery

    mmol/l

  3. Changes in osmolarity

    Time frame: 1 hour after hypertonic NaCl infusion

    mosm/l

  4. Changes in osmolarity

    Time frame: 5 min after the end of surgery

    mosm/l

  5. Concentration of natrium in cerebrospinal fluid

    Time frame: after dura opening

    mmol/l

Other outcomes

  1. Changes in diuresis

    Time frame: at the time of extubation

    ml/hour

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2015
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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