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

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01013090
First received: November 12, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Cesarean Section
Drug: Ringer's Lactate
Drug: Six percent hydroxyethyl starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of hypotension after ephedrine or phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Consumption of ephedrine and phenylephrine [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Duration of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Oxygen saturation during hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
  • One-min and 5-min Apgar scores [ Time Frame: The first and fifth minute after cesarean successful delivery ] [ Designated as safety issue: Yes ]
  • Low umbilical cord pH (artery < 7.20) [ Time Frame: At the time of successful delivery (0 min) ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: HES/HAES

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013090

Locations
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01013090     History of Changes
Other Study ID Numbers: NMU-200911-MZ020, NJFY09331M041
Study First Received: November 12, 2009
Last Updated: December 22, 2009
Health Authority: China: Ministry of Health
China: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Epidural anesthesia
Spinal anesthesia
Combined spinal-epidural anesthesia
Fluid therapy
Crystalloid
Colloid

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Hydroxyethyl Starch Derivatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on September 30, 2014