NCT00987701

Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,000 (actual)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DRUG	Ringer's Lactate	Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section
DRUG	Six percent hydroxyethyl starch	Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-10-01
• Last updated: 2011-07-27

Locations

1 site across 1 country: China