Skip to content

Fluid Management for Cesarean Section III

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00973414
Acronym
FMCS-III
Enrollment
850
Registered
2009-09-09
Start date
2009-03-31
Completion date
2009-09-30
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

Combined epidural spinal anesthesia, Fluid therapy

Brief summary

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.

Interventions

DRUGRinger's Lactate

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

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

Sponsors

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