Clinical trial NCT02070276: Predict Fluid Responsiveness in Spinal Anesthesia
Official title: Can Non Invasive Methods for Fluid Responsive Assessment Optimize Preventive Volemic Repletion in Order to Prevent Significant Hypotension After Spinal Anesthesia? A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension and Shock
Excessive Amount of Blood / Fluid Infusion
Keywords: Fluid therapy
Hypotension
Inferior vein cava
Spinal anesthesia
Ultrasonography
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The resulting high density of the anesthetic block and the reproducibility of the technique have made of spinal anesthesia the most widely diffused regional anesthesia technique. Nevertheless the procedure still remains the regional anesthesia technique burdened by the potentially most severe side effects, the most frequent of which being systemic arterial hypotension.

Subarachnoidal administration of local anesthetics in fact is associated not only with both a motor and sensory block, but also with a blockade of the autonomic nervous system, which controls peripheral vascular tone. Sympathetic block leads to a sudden decrease in peripheral resistance, with consequent significant increase in vascular bed and relative hypovolemia.

Transient hypotensive episodes can be generally well tolerated by healthy patients, however they may lead to major complications in patients with increased cardiovascular risk. In the common clinical practice, it is usual to administer fluids empirically. An empirical preventive fluid repletion however can represent per se a risk in patients with impaired cardiac and renal functions, since a volume overload of heart chambers with reduced compliance can cause pulmonary edema or congestive heart failure.

Since about ten years both non-invasive and invasive techniques have been developed, with the specific purpose of optimizing fluid status on a rational basis. This methods are based on the correlation between the levels of mean arterial pressure (MAP), systemic vascular resistance (SVR) and cardiac output (CO), according to the equation: MAP = CO \* SVR. The latter explains why, in case of vasodilation, unless CO is increased, a lowering of SVR will inevitably translate into a decrease of MAP.

Determinants of blood pressure are:

1. volemic status;
2. vascular resistance (determined by the control of the sympathetic system);
3. cardiac output.

In case of spinal anesthesia the reduction in SVR determines relative hypovolemia (due to an increase in total vascular bed). For this reason after spinal anesthesia appears fundamental an optimization of patients' volemic status through administration of fluids (eventually associated with the administration of amines, in order to contrast massive vasodilation).

The use of methods to assess fluid responsiveness has been extensively studied in critical patients populations. However these techniques have not been studied yet in non critical patients. Spinal anesthesia is a model of pharmacological vasodilation which often generates significant hypotension, for which nowadays an evidence-based rational treatment based on a guided volemic repletion is still lacking.

WORKING HYPOTHESIS:

The use of non-invasive methods that have proven to be accurate for the identification of patient fluid-responsiveness is currently not validated in patients undergoing spinal anesthesia.

Ultrasound of inferior vena cava by is an effective method to determine the responsiveness to fluids in a patient on mechanical ventilation, however it has been proven to be inaccurate in spontaneous ventilating patients in critically ill patients, few data being available in non critical patients. The study of the inferior vena cava is based on the size of the inferior vena cava in its intra-abdominal portion (approximately 2 cm from emergency right atrium) and the pattern of its diameter changes with breathing. This measurement is obtained with M-mode ultrasound through subcostal view..

Passive leg raising test (PLRT) has been proven to be a highly accurate method in predicting fluid responsiveness in spontaneously breathing patients, in a population of critically ill patients. The method is based on the following assumption: active legs elevation, in addition to its effect of venous pool shifting from the lower limbs to the thorax, exerts a contemporary effect of stimulation on the peri-arterial sympathetic system at iliac-femoral level, this causing an orthosympathetic reflex which can increase cardiac output, possibly masking hypovolemia. Passive lower limbs raising instead has the advantage of mobilizing lower limbs venous blood (estimated 300-500 ml), without activating the orthosympathetic reflex. This allows for a quantification of the clinical response to a bolus of fluids, in terms of decrease of blood pressure variations following leg raising.

The hypothesis that investigators want to test is that the use of inferior vena cava ultrasound before spinal anesthesia, compared to the standard method (empirical fluid administration) and a non-invasive method (PLRT) can reduce the impact of systemic hypotension through an adequate titrated volemic repletion, avoiding both hypotension and fluid overload. The final purpose is to ensure spinal anesthesia in the safest possible way.

OBJECTIVES OF THE STUDY:

Aim of the study is to determine whether vena cava ultrasound, a bedside, unexpensive, non invasive methods, which have been tested as predictors of fluid responsiveness in critical patients, is effective in guiding titrated fluid repletion in a non critical population, in order both to decrease post procedural significant hypotension rate and unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical procedures.

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)

Primary outcomes:
measure: Percentage of Participants With Systemic Hypotensions
timeFrame: 30 minutes
Secondary outcomes:
measure: Pre-anesthesia Fluid Amount
timeFrame: Time between operating room entry and spinal anesthesia, up to 30 min.
measure: Post-anesthesia Fluid Amount
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona
Study officials:
affiliation: Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona
name: Samuele Ceruti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona
name: Andrea Saporito, MD
role: STUDY_CHAIR
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