Fluid Management for Cesarean Section II

Study Overview
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Brief Summary
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Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.

Official Title
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Fluid Management for Cesarean Section Undergoing Spinal Anesthesia

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Ringer's Lactate
* Drug: Six percent hydroxyethyl starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21-40 yr First time of delivery ASA status I-II No premature No genetic and infectious diseases Chinese Exclusion Criteria: < 21 yr > 40 yr Subjects with cardiac and pulmonary disorders Dislocation of placenta Pregnant hypertension Allergy to local anesthetics Unwilling to cooperation Need intraoperative administration of vascular active agents With significant delivery side effects

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prior crystalloid<br>Crystalloid (Ringer's Lactate) was given before spinal anesthesia | Drug: Ringer's Lactate<br>* Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section<br>* Other names: Lactated Ringer's solution;|
| Active Comparator: Posterior crystalloid<br>Crystalloid (Ringer's Lactate) was given after spinal anesthesia | Drug: Ringer's Lactate<br>* Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section<br>* Other names: Lactated Ringer's solution;|
| Active Comparator: Prior colloid<br>Colloid (6% hydroxyethyl starch) was given before spinal anesthesia | Drug: Six percent hydroxyethyl starch<br>* Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section<br>* Other names: HES/HAES;|
| Active Comparator: Posterior colloid<br>Colloid (6% hydroxyethyl starch) was given after spinal anesthesia | Drug: Six percent hydroxyethyl starch<br>* Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section<br>* Other names: HES/HAES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypotension |  | Anesthesia begin (0 min) to 120 min after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of hypotension after ephedrine or phenylephrine |  | Anesthesia begin (0 min) to 120 min after anesthesia | 
| Consumption of ephedrine and phenylephrine |  | Anesthesia begin (0 min) to 120 min after anesthesia | 
| Total volume of colloid or crystalloid |  | Fifteen minutes before anesthesia to 120 min after anesthesia | 
| One-min and 5-min Apgar scores |  | The first and fifth minute after cesarean successful delivery | 
| Oxygen saturation during hypotension |  | Anesthesia begin (0 min) to 120 min after anesthesia | 
| Duration of hypotension |  | Anesthesia begin (0 min) to 120 min after anesthesia | 
| Low umbilical cord pH (artery < 7.20) |  | At the time of successful delivery (0 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal anesthesia, Fluid therapy