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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumors
• Intervention / Treatment: Procedure: 1.5% NaCl; Procedure: 3% NaCl

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Hradec Kralove, Czechia, 50005
    • University hospital Hradec Králové

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain microcirculation	measurement by SDF probe MicroVision	from dura opening till the end of tumor resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in natremia	mmol/l	1 hour after hypertonic NaCl infusion
Changes in natremia	mmol/l	5 min after the end of surgery
Changes in osmolarity	mosm/l	1 hour after hypertonic NaCl infusion
Changes in osmolarity	mosm/l	5 min after the end of surgery
Concentration of natrium in cerebrospinal fluid	mmol/l	after dura opening

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diuresis	ml/hour	at the time of extubation

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove
• Investigators: Principal Investigator: Vlasta Dostalova, MD., University hospital Hradec Králové

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Brain Tumors; Osmotherapy; Microcirculation; Hypertonic NaCl; Natremia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 201508-S23P