NCT04404946

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aretaieion University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

Detailed description

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.

Conditions

• Hypotension Symptomatic
• Vasoconstriction
• Cesarean Section Complications
• Obstetric Anesthesia Problems

Interventions

Type	Name	Description
OTHER	phenylephrine infusion	in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated
OTHER	norepinephrine infusion	in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated
OTHER	placebo infusion	in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Timeline

• Start date: 2020-05-23
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-05-28
• Last updated: 2021-06-15

Locations

1 site across 1 country: Greece