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Fluid replacement in patients undergoing neurosurgery

Evaluation of Plasma-Lyte and 0.9% Sodium Chloride Administration in Hydroelectrolytic Balance, Acid-Base, and Renal Function in Neurosurgery: Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2592hd
Enrollment
Unknown
Registered
2019-10-20
Start date
2019-01-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with intracranial tumor or aneurysm

Interventions

Saline group (SF): 28 patients who will have their intraoperative volume replacement performed with intravenous 0.9% saline administration at the infusion rate necessary to maintain hemodynamic stabil
Drug
Q65.070
C10.228.140.300.510.600
C04.557.470.200.240

Sponsors

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing neurosurgery, tumor resection, or aneurysm clamping and who are 18 years of age and older and classified as physical status ASA I, II, and III, according to the American Society of Anesthesiologists classification.

Exclusion criteria

Exclusion criteria: Patients or legal representative who do not accept to participate in the study, with refusal to sign the consent form; patients under 18 years old; any other neurosurgical procedure other than tumor resection or aneurysm clipping (head trauma, ventriculo-peritoneal shunt, etc.), patients with chronic kidney injury, pre-existing abnormality of acid-base and electrolyte disorder, pregnant women and patients in use of previous diuretics.

Design outcomes

Primary

MeasureTime frame
To verify the alteration of the acid-base and hydroelectrolytic balance by means of arterial blood gas measurement (PaO2, PaCO2, BE, HCO3), plasma electrolytes (Na +, K +, calcium, mg ++) and plasma lactate—

Secondary

MeasureTime frame
Hemodynamic stability verified by measuring blood pressure, heart rate, oxygen saturation and expired CO2 pressure Presence of acute kidney injury assessed by diuresis and plasma creatinine Surgical condition assessment performed by the surgeon Presence of postoperative complications (extubation time (min) ICU stay (days) Length of hospital stay (days) Mortality at 24 hours, seven, 30 and 90 days—

Countries

Brazil

Contacts

Public ContactNorma Sueli Módolo

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP

norma.p.modolo@unesp.br55-14-38801407

Outcome results

None listed

Source: REBEC (via WHO ICTRP)