Cesarean Section
Conditions
Keywords
Epidural anesthesia, Spinal anesthesia, Combined spinal-epidural anesthesia, Fluid therapy, Crystalloid, Colloid
Brief summary
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
Interventions
DRUGRinger's Lactate
Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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 * With contradictions of neuraxial anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hypotension | Anesthesia begin (0 min) to 120 min after anesthesia |
Secondary
| Measure | Time frame |
|---|---|
| Consumption of ephedrine and phenylephrine | Anesthesia begin (0 min) to 120 min after anesthesia |
| Duration of hypotension | Anesthesia begin (0 min) to 120 min after anesthesia |
| Recurrence of hypotension after ephedrine or phenylephrine | Anesthesia begin (0 min) to 120 min after anesthesia |
| One-min and 5-min Apgar scores | The first and fifth minute after cesarean successful delivery |
| Low umbilical cord pH (artery < 7.20) | At the time of successful delivery (0 min) |
| Oxygen saturation during hypotension | Anesthesia begin (0 min) to 120 min after anesthesia |
Countries
China
Outcome results
None listed