Fluid Coloading and the Incidence of Hypotension

Çukurova University

Status and phase: Completed; Phase 4

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

Treatments: Biological: Cristalloid and colloid coloading

Study type: Interventional

Funder types: Other

Identifiers

NCT01741610

HZLTNS97

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 19 to 46 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

No coloading (Group E)

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Biological: Cristalloid and colloid coloading

Cristalloid (Lactated Ringer) Coloading

Active Comparator group

Description:

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

Treatment:

Biological: Cristalloid and colloid coloading

Colloid (HES) coloading

Active Comparator group

Description:

Colloid (HES) coloading (Group C)

Treatment:

Biological: Cristalloid and colloid coloading