University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
NCT Number: NCT02537106
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hradec Králové, 50005, Czechia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: from dura opening till the end of tumor resection
measurement by SDF probe MicroVision
Time frame: 1 hour after hypertonic NaCl infusion
mmol/l
Time frame: 5 min after the end of surgery
mmol/l
Time frame: 1 hour after hypertonic NaCl infusion
mosm/l
Time frame: 5 min after the end of surgery
mosm/l
Time frame: after dura opening
mmol/l
Time frame: at the time of extubation
ml/hour
University Hospital Hradec Kralove
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01875601
Brain Diseases, Brain Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT04128306
Brain Diseases, Brain Neoplasms
Toulouse, France
View Trial DetailsNCT00850278
Brain Diseases, Brain Neoplasms
Caen, France
View Trial DetailsNCT07321262
Brain Diseases, Brain Neoplasms
Beijing, Beijing Municipality, China
View Trial Details