Trial | NCT01741610  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
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.
Study Started
Oct 31
2008
Primary Completion
Aug 31
2011
Study Completion
Jun 30
2012
Last Update
Jan 15
2014
Estimate

Biological Cristalloid and colloid coloading

Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator

  • Other names: Cristalloid coloading (Group L), Colloid coloading (Group C), No coloading (Group E)Placebo Comparator

No coloading (Group E) Placebo Comparator

Placebo comparator

Cristalloid (Lactated Ringer) Coloading Active Comparator

Cristalloid (Lactated Ringer's) Coloading (Group L)

Colloid (HES) coloading Active Comparator

Colloid (HES) coloading (Group C)

Criteria 

Inclusion Criteria:

elective caesarean section under spinal anaesthesia

Exclusion Criteria:

Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
Pregnancy preinduced hypertension,
Being in active labour or requiring emergency caesarean section,
Any contraindication to regional anaesthesia such as local infection or bleeding disorders.
No Results Posted