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

NCT02537106 | Completed

• 1 other identifier: 201508-S23P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumors

Keywords

Brain Tumors; Microcirculation; Osmotherapy; Hypertonic NaCl; Natremia

Outcome Measures

Primary Outcomes (1)

• Changes in brain microcirculation

  measurement by SDF probe MicroVision

  from dura opening till the end of tumor resection

Secondary Outcomes (5)

• Changes in natremia

  1 hour after hypertonic NaCl infusion

• Changes in natremia

  5 min after the end of surgery

• Changes in osmolarity

  1 hour after hypertonic NaCl infusion

• Changes in osmolarity

  5 min after the end of surgery

• Concentration of natrium in cerebrospinal fluid

  after dura opening

Other Outcomes (1)

• Changes in diuresis

  at the time of extubation

Study Arms (2)

1.5% NaCl

EXPERIMENTAL

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

3% NaCl

EXPERIMENTAL

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

Interventions

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.

1.5% NaCl

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.

3% NaCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• peripheral supratentorial brain tumors or metastasis
• indication for osmotherapy
• ASA status I-III

You may not qualify if:

• reoperation
• osmotherapy prior to surgery
• preoperative natremia less than 135 mmol/l and more than 140 mmol/l
• GCS less than 14
• obstructive hydrocephalus

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vlasta Dostalova, MD.

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dostalova Vlasta, MD, PhD

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CZ (1)