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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741610

Enrollment

Registered

2012-12-05

Start date

2008-10-31

Completion date

2012-06-30

Last updated

2014-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension

Brief 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.

Interventions

BIOLOGICALCristalloid and colloid coloading

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 46 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading	Four Years	The primary study endpoint was the ephedrine requirement (incidence of hypotension).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026