Fluid Coloading and the Incidence of 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.

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Key information

Conditions

Complications; Cesarean Section Anesthesia; Adverse Effect, Spinal and Epidural Cardiovascular Diseases Hypotension Other Fluid Overload Vascular Diseases

Age range

19 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hakki Unlugenc

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cristalloid and colloid coloading

Biological

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

Primary outcomes

Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading

Time frame: Four Years

The primary study endpoint was the ephedrine requirement (incidence of hypotension).

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Dec 5, 2012
Registry last updated: Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed