Asst Papa Giovanni Xxiii
Bergamo, 24127, Italy
NCT Number: NCT03653442
Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications.
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Notify Me18 year–45 year
Female
Observational
Bergamo, 24127, Italy
Hypotension induced by neuraxial anaesthesia (NA-induced hypotension) is defined as systolic blood pressure (SBP) less than 100 mmHg or a decrease of 20-30% from baseline values. The incidence of hypotension could exceed 71% and can cause, if serious and prolonged, nausea, vomiting, lost of consciousness, placental hypoperfusion and foetal acidosis.
There are two alternative hypotheses to explain why hypotension might be so commonly diagnosed after regional analgesia during labour: preload reduction theory and afterload reduction theory. A non-invasive continue haemodynamic monitoring could be useful in detecting pregnant women with a positive preoperative supine stress, at increased risk for clinically significant hypotension during Caesarean section under spinal anaesthesia. These women seem more likely to benefit from optimizing the administration of fluids and vasoconstrictors to maintain pressure and cardiac output at basal levels.
Predictors of clinical need of therapy to counteract symptomatic hypotension (dependant variable) will be sought by using regression logistic analysis. Putative variable to include in the model will be selected through clinical and statistical criteria. Univariate screening will be performed assuming the usual cut-off of p<0,1 and taking into account the biological relevance. The final variable to challenge in the multivariate model will be selected according to the parsimony criteria in order to avoid overfitting and multicollinearity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Diastolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Mean arterial blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Heart rate in beats per minute) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Cardiac output in L/min) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Stroke volume in mL/beat) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systemic vascular resistance in dynes - sec/cm^5) and neuraxial anaesthesia induced hypotension (clinical end point)
Time frame: from immediately after induction of spinal anaesthesia to 15 minutes later
Neuraxial induced hypotension is defined as a reduction of SBP < 100 mmHg or a decrease by 20 - 30%, compared to basal value
Papa Giovanni XXIII Hospital
Other
Non-invasive Haemodynamic Parameters Predictive of Hypotension Induced by Neuraxial Anaesthesia During Elective Caesarean Section
Acronym: NIHNAH
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