Cesarean Section, Spinal Anesthesia, Parturition
Conditions
Brief summary
Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section
Detailed description
The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section
Interventions
DRUGhydroxyethl starch
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
Sponsors
China International Neuroscience Institution
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20 to 40 years old.
Exclusion criteria
* History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypotension | during operation procedure | The incidence of maternal hypotension during the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| umbilical vein blood gases | 24 hours | umbilical vein blood gases |
| umbilical artery blood gases | 24 hours | umbilical artery blood gases |
| Maternal vein blood gase | 24 hours | Maternal vein blood gase |
| The incidences of maternal complications | 24 hours | The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively. |
| Hemodynamic data at time point | 24 hours | Hemodynamic data at time point |
Countries
China
Outcome results
None listed