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

Primary Purpose

Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ringer's Lactate
Six percent hydroxyethyl starch
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring Epidural anesthesia, Spinal anesthesia, Combined spinal-epidural anesthesia, Fluid therapy, Crystalloid, Colloid

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Nanjing Maternity and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Epidural crystalloid

Epidural colloid

Spinal crystalloid

Spinal colloid

CSEA crystalloid

CSEA colloid

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Rate of hypotension

Secondary Outcome Measures

Recurrence of hypotension after ephedrine or phenylephrine
Consumption of ephedrine and phenylephrine
Duration of hypotension
Oxygen saturation during hypotension
One-min and 5-min Apgar scores
Low umbilical cord pH (artery < 7.20)

Full Information

First Posted
November 12, 2009
Last Updated
December 22, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01013090
Brief Title
Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia
Acronym
VOHOCUNA
Official Title
Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
Epidural anesthesia, Spinal anesthesia, Combined spinal-epidural anesthesia, Fluid therapy, Crystalloid, Colloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural crystalloid
Arm Type
Active Comparator
Arm Description
Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section
Arm Title
Epidural colloid
Arm Type
Active Comparator
Arm Description
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section
Arm Title
Spinal crystalloid
Arm Type
Active Comparator
Arm Description
Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section
Arm Title
Spinal colloid
Arm Type
Active Comparator
Arm Description
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section
Arm Title
CSEA crystalloid
Arm Type
Active Comparator
Arm Description
Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section
Arm Title
CSEA colloid
Arm Type
Active Comparator
Arm Description
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section
Intervention Type
Drug
Intervention Name(s)
Ringer's Lactate
Other Intervention Name(s)
Lactated Ringer's solution
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Six percent hydroxyethyl starch
Other Intervention Name(s)
HES/HAES
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of hypotension
Time Frame
Anesthesia begin (0 min) to 120 min after anesthesia
Secondary Outcome Measure Information:
Title
Recurrence of hypotension after ephedrine or phenylephrine
Time Frame
Anesthesia begin (0 min) to 120 min after anesthesia
Title
Consumption of ephedrine and phenylephrine
Time Frame
Anesthesia begin (0 min) to 120 min after anesthesia
Title
Duration of hypotension
Time Frame
Anesthesia begin (0 min) to 120 min after anesthesia
Title
Oxygen saturation during hypotension
Time Frame
Anesthesia begin (0 min) to 120 min after anesthesia
Title
One-min and 5-min Apgar scores
Time Frame
The first and fifth minute after cesarean successful delivery
Title
Low umbilical cord pH (artery < 7.20)
Time Frame
At the time of successful delivery (0 min)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 Need intraoperative administration of vascular active agents With significant delivery side effects With contradictions of neuraxial anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia

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