N/A
Completed N=429
Predict Fluid Responsiveness in Spinal Anesthesia
Hypotension and Shock · Excessive Amount of Blood / Fluid Infusion
Source: ClinicalTrials.gov NCT02070276 ↗
Enrolled (actual)
429
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With Systemic Hypotensions — 68; 46; 65 Participants
Summary
Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday clinical practice.
The most feared and common of its well known side effects consist in an abrupt reduction of systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this potentially severe complication, an adequate correction of patients' volume status through a preventive administration of fluids is widely used.
However this volume repletion is commonly accomplished on an empirical basis, without having a real insight of patient hemodynamic status, carrying the risk of possible volume overload.
Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide volemic repletion before spinal anesthesia on the reduction of significant hypotension rate, compared to empirical fluid administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Systemic Hypotensions |
68; 46; 65 | — |
| SECONDARY Pre-anesthesia Fluid Amount |
141; 336; 168 | — |
| SECONDARY Post-anesthesia Fluid Amount |
312; 257; 342 | — |
Eligibility Criteria
Inclusion Criteria
- all adult non critical patients requiring elective spinal anesthesia
- both sex
- patients with American Society of Anesthesiology class level I, II and III according to international standards
- spontaneously breathing patients
Exclusion Criteria
- patients already equipped or requiring invasive blood pressure monitoring (arterial catheter, pulmonary catheter, thermodilution catheter)
- patients with pre-procedural hypotension, defined as a response in two consecutive measurements of systolic arterial pressure (SAP) less than 80 mmHg or mean arterial pressure (MAP) less of 60 mmHg.
- patients unable to give informed consent to communication difficulties to language barriers or processes congenital/acquired determinants of mental retard, or any reduction in their ability to understand or want to be able to give their informed consent to the study
- patients where it is not then possible to perform spinal anesthesia for the patient's refusal to technical difficulties in sampling, clinical pathological conditions for determining a high risk of peri- procedural complications.
- patients with International Normalized Ratio > 1.5 and/or activated partial thromboplastin time in therapeutic range (defined as a value more than 1.5-2 times the normal values of the patient), anti-Xa activity in the therapeutic range .
- patients with severe thrombocytopenia (<50 G/l)
Data sourced from ClinicalTrials.gov (NCT02070276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.