Fluid Management for Cesarean Section III (FMCS-III)

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

NCT00973414

NJMU-09053MZ

Details and patient eligibility

About

Regional anesthesia, including epidural, spinal and combined epidural spinal anesthesia (CSEA), is a pivotal part in modern anesthesiology. Previously, the investigators found that epidural and spinal anesthesia during cesarean section possesses different responsiveness to fluid (including crystalloid and colloid) management given prior or posterior to anesthesia. Although CSEA is also widely used as an alternative of single epidural or spinal anesthesia for its combined effect of fast onset of anesthesia of spinal anesthesia and the property of duration of epidural catheterization, the fluid resuscitation during CSEA is still unknown. The investigators hypothesized that fluid management during CSEA would produce different effect on hemodynamics in cesarean section compared with epidural and spinal anesthesia.

Enrollment: 850 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
• Need intraoperative administration of vascular active agents
• With significant delivery side effects

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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850 participants in 4 patient groups

Prior crystalloid

Active Comparator group

Description:

Crystalloid (Ringer's Lactate) was given before CSEA

Treatment:

Drug: Ringer's Lactate

Posterior crystalloid

Active Comparator group

Description:

Crystalloid (Ringer's Lactate) was given after CSEA

Treatment:

Drug: Ringer's Lactate

Prior colloid

Active Comparator group

Description:

Colloid (6% hydroxyethyl starch) was given before CSEA

Treatment:

Drug: Six percent hydroxyethyl starch

Posterior colloid

Active Comparator group

Description:

Colloid (6% hydroxyethyl starch) was given after CSEA

Treatment:

Drug: Six percent hydroxyethyl starch