Fluid Coloading and the Incidence of Hypotension

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Biological: Cristalloid and colloid coloading


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No coloading (Group E)<br>Placebo comparator | Biological: Cristalloid and colloid coloading<br>* Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator<br>* Other names: No coloading (Group E)Placebo Comparator;|
| Active Comparator: Cristalloid (Lactated Ringer) Coloading<br>Cristalloid (Lactated Ringer's) Coloading (Group L) | Biological: Cristalloid and colloid coloading<br>* Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator<br>* Other names: No coloading (Group E)Placebo Comparator;|
| Active Comparator: Colloid (HES) coloading<br>Colloid (HES) coloading (Group C) | Biological: Cristalloid and colloid coloading<br>* Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator<br>* Other names: No coloading (Group E)Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension