NCT03653442

Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension

Non-invasive Haemodynamic Parameters Predictive of Hypotension Induced by Neuraxial Anaesthesia During Elective Caesarean Section

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Papa Giovanni XXIII Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypotension, Controlled
• Anaesthesia, Spinal
• Caesarean Section

Timeline

• Start date: 2018-06-10
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2018-08-31
• Last updated: 2020-03-04

Locations

1 site across 1 country: Italy