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Fluid Management for Cesarean Section II

Fluid Management for Cesarean Section Undergoing Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00973791
Acronym
FMCS-II
Enrollment
860
Registered
2009-09-09
Start date
2008-10-31
Completion date
2009-05-31
Last updated
2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Spinal anesthesia, Fluid therapy

Brief summary

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.

Interventions

DRUGRinger's Lactate

Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section

Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section

Sponsors

Nanjing Maternity and Child Health Care Hospital
CollaboratorOTHER
Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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

Design outcomes

Primary

MeasureTime frame
Rate of hypotensionAnesthesia begin (0 min) to 120 min after anesthesia

Secondary

MeasureTime frame
Consumption of ephedrine and phenylephrineAnesthesia begin (0 min) to 120 min after anesthesia
Total volume of colloid or crystalloidFifteen minutes before anesthesia to 120 min after anesthesia
One-min and 5-min Apgar scoresThe first and fifth minute after cesarean successful delivery
Recurrence of hypotension after ephedrine or phenylephrineAnesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotensionAnesthesia begin (0 min) to 120 min after anesthesia
Low umbilical cord pH (artery < 7.20)At the time of successful delivery (0 min)
Oxygen saturation during hypotensionAnesthesia begin (0 min) to 120 min after anesthesia

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026