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

Sponsor
University Hospital Hradec Kralove (Other)
Overall Status
Completed
CT.gov ID
NCT02537106
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
44
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: 1.5% NaCl
  • Procedure: 3% NaCl
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Sep 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in brain microcirculation [from dura opening till the end of tumor resection]

    measurement by SDF probe MicroVision

Secondary Outcome Measures

  1. Changes in natremia [1 hour after hypertonic NaCl infusion]

    mmol/l

  2. Changes in natremia [5 min after the end of surgery]

    mmol/l

  3. Changes in osmolarity [1 hour after hypertonic NaCl infusion]

    mosm/l

  4. Changes in osmolarity [5 min after the end of surgery]

    mosm/l

  5. Concentration of natrium in cerebrospinal fluid [after dura opening]

    mmol/l

Other Outcome Measures

  1. Changes in diuresis [at the time of extubation]

    ml/hour

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Hradec Kralove Hradec Kralove Czechia 50005

Sponsors and Collaborators

  • University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Vlasta Dostalova, MD., University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dostalova Vlasta, MD, PhD, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier:
NCT02537106
Other Study ID Numbers:
  • 201508-S23P
First Posted:
Sep 1, 2015
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Keywords provided by Dostalova Vlasta, MD, PhD, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
Brain Tumors
Microcirculation
Osmotherapy
Hypertonic NaCl
Natremia
Additional relevant MeSH terms:
Brain Neoplasms

Study Results

No Results Posted as of Oct 1, 2019