drugset / Trial / NCT04026685

Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

NCT04026685

RandomizedParallel-groupDouble-blindTreatment

Summary

Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.

Timeline

Start
2020-01-09
Primary completion
2021-02-05
Completion
2021-02-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Phenylephrine Small molecule 25 ug
Comparator Ringer acetate Other / unclassified 1000 ml

Indications

No indication recorded.