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Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00987701
Acronym
PAFUMIN
Enrollment
5000
Registered
2009-10-01
Start date
2009-09-30
Completion date
2011-05-31
Last updated
2011-07-27

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

Conditions

Cesarean Section

Keywords

Neurobehavior, Development, Fluid management, Neuraxial anesthesia

Brief summary

Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.

Interventions

DRUGRinger's Lactate

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

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

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 * With significant delivery side effects

Design outcomes

Primary

MeasureTime frame
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)Immediate after birth (0 min)

Secondary

MeasureTime frame
Umbilical-cord gases analysisAt the time baby was born (0min)
Neonatal sepsis evaluationOne hour after the baby was born
Apgar scoringOne min and 5min after birth.
Incidence of maternal side effectsAnalgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)30min after birth
Neonatal antibiotic treatmentOne hour after the baby was born

Countries

China

Outcome results

None listed

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