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

Brain Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537106
• Other study ID #: 201508-S23P
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in diuresis	ml/hour	at the time of extubation
Primary	Changes in brain microcirculation	measurement by SDF probe MicroVision	from dura opening till the end of tumor resection
Secondary	Changes in natremia	mmol/l	1 hour after hypertonic NaCl infusion
Secondary	Changes in natremia	mmol/l	5 min after the end of surgery
Secondary	Changes in osmolarity	mosm/l	1 hour after hypertonic NaCl infusion
Secondary	Changes in osmolarity	mosm/l	5 min after the end of surgery
Secondary	Concentration of natrium in cerebrospinal fluid	mmol/l	after dura opening