Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors (PAFUMIN)

Nanjing Medical University

Status: Completed

Conditions: Cesarean Section

Treatments: Drug: Six percent hydroxyethyl starch; Drug: Ringer's Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT00987701

NJMU-0932MZ

NMUK2190

Details and patient eligibility

About

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.

Enrollment: 5,000 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 2 patient groups

Crystalloid resuscitation

Active Comparator group

Description:

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

Treatment:

Drug: Ringer's Lactate

Colloid resuscitation

Active Comparator group

Description:

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

Treatment:

Drug: Six percent hydroxyethyl starch