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

Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural crystalloid; Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section	Drug: Ringer's Lactate; Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: Lactated Ringer's solution
Active Comparator: Epidural colloid; Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section	Drug: Six percent hydroxyethyl starch; Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: HES/HAES
Active Comparator: Spinal crystalloid; Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section	Drug: Ringer's Lactate; Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: Lactated Ringer's solution
Active Comparator: Spinal colloid; Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section	Drug: Six percent hydroxyethyl starch; Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: HES/HAES
Active Comparator: CSEA crystalloid; Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section	Drug: Ringer's Lactate; Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: Lactated Ringer's solution
Active Comparator: CSEA colloid; Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section	Drug: Six percent hydroxyethyl starch; Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Other Names: HES/HAES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence of hypotension after ephedrine or phenylephrine	Anesthesia begin (0 min) to 120 min after anesthesia
Consumption of ephedrine and phenylephrine	Anesthesia begin (0 min) to 120 min after anesthesia
One-min and 5-min Apgar scores	The first and fifth minute after cesarean successful delivery
Oxygen saturation during hypotension	Anesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia
Low umbilical cord pH (artery < 7.20)	At the time of successful delivery (0 min)

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 22, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Crystalloid; Fluid therapy; Epidural anesthesia; Colloid; Combined spinal-epidural anesthesia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: NMU-200911-MZ020; NJFY09331M041 (Other Grant/Funding Number: Nanjing Medical University)