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Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

NCT00987701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2011-07-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • XiaoFeng Shen, MD · Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987701 on ClinicalTrials.gov