Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

NCT ID: NCT00987701

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Crystalloid resuscitation

Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia

Group Type: ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type: DRUG

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

Colloid resuscitation

Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia

Group Type: ACTIVE_COMPARATOR

Six percent hydroxyethyl starch

Intervention Type: DRUG

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

Interventions

Ringer's Lactate

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

Intervention Type: DRUG

Six percent hydroxyethyl starch

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

Intervention Type: DRUG

Other Intervention Names

Lactated Ringer's solution; HES/HAES

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nanjing Medical University

Principal Investigators

XiaoFeng Shen, MD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NMUK2190

Identifier Type: -

Identifier Source: secondary_id

NJMU-0932MZ

Identifier Type: -

Identifier Source: org_study_id