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

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ClinicalTrials.gov Identifier: NCT02537106
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

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.

Condition or disease Intervention/treatment Phase
Brain Tumors Procedure: 1.5% NaCl Procedure: 3% NaCl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Changes in brain microcirculation [ Time Frame: from dura opening till the end of tumor resection ]
    measurement by SDF probe MicroVision


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Changes in diuresis [ Time Frame: at the time of extubation ]
    ml/hour



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537106


Locations
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Czechia
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
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Principal Investigator: Vlasta Dostalova, MD. University Hospital Hradec Kralove
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Responsible Party: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT02537106    
Other Study ID Numbers: 201508-S23P
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove:
Brain Tumors
Microcirculation
Osmotherapy
Hypertonic NaCl
Natremia
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases