Fluid Management for Cesarean Section III (FMCS-III)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00973414
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


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: Open Label
Primary Purpose: Supportive Care
Official Title: Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)

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 ]
  • Total volume of colloid or crystalloid [ Time Frame: Fifteen minutes before anesthesia 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 ]
  • Oxygen saturation during hypotension [ 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 ]
  • Low umbilical cord pH (artery < 7.20) [ Time Frame: At the time of successful delivery (0 min) ] [ Designated as safety issue: Yes ]

Enrollment: 850
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prior crystalloid
Crystalloid (Ringer's Lactate) was given before CSEA
Drug: Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section
Other Name: Lactated Ringer's solution
Active Comparator: Posterior crystalloid
Crystalloid (Ringer's Lactate) was given after CSEA
Drug: Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section
Other Name: Lactated Ringer's solution
Active Comparator: Prior colloid
Colloid (6% hydroxyethyl starch) was given before CSEA
Drug: Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section
Other Name: HES/HAES
Active Comparator: Posterior colloid
Colloid (6% hydroxyethyl starch) was given after CSEA
Drug: Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00973414

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

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00973414     History of Changes
Other Study ID Numbers: NJMU-09053MZ
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: China: Nanjing Bureau of Health
China: Nanjing Medical University

Keywords provided by Nanjing Medical University:
Combined epidural spinal anesthesia
Fluid therapy

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014