NCT01741610

Fluid Coloading and the Incidence of Hypotension

Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: Female
• Age: 19 Years – 46 Years
• Healthy volunteers: Accepted

Summary

This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Detailed description

Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Conditions

• Complications; Cesarean Section
• Anesthesia; Adverse Effect, Spinal and Epidural
• Other Fluid Overload

Interventions

Type	Name	Description
BIOLOGICAL	Cristalloid and colloid coloading	Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-08-01
• Completion: 2012-06-01
• First posted: 2012-12-05
• Last updated: 2014-01-15

Locations

1 site across 1 country: Turkey (Türkiye)