Fluid Management for Cesarean Section III

Study Overview
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Brief Summary
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Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.

Official Title
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Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)

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