Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia (VOHOCUNA)

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

NCT01013090

NMU-200911-MZ020

NJFY09331M041 (Other Grant/Funding Number)

Details and patient eligibility

About

Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.

Enrollment: 1,000 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
• Need intraoperative administration of vascular active agents
• With significant delivery side effects
• With contradictions of neuraxial anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 6 patient groups

Epidural crystalloid

Active Comparator group

Description:

Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Ringer's Lactate

Epidural colloid

Active Comparator group

Description:

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Six percent hydroxyethyl starch

Spinal crystalloid

Active Comparator group

Description:

Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Ringer's Lactate

Spinal colloid

Active Comparator group

Description:

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Six percent hydroxyethyl starch

CSEA crystalloid

Active Comparator group

Description:

Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Ringer's Lactate

CSEA colloid

Active Comparator group

Description:

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section

Treatment:

Drug: Six percent hydroxyethyl starch