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

September 8, 2009
September 8, 2009
March 2009
September 2009   (final data collection date for primary outcome measure)
Rate of hypotension [ Time Frame: Anesthesia begin (0 min) to 120 min after anesthesia ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Fluid Management for Cesarean Section III
Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cesarean Section
  • 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
  • Drug: Six percent hydroxyethyl starch
    Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section
    Other Name: HES/HAES
  • Active Comparator: Prior crystalloid
    Crystalloid (Ringer's Lactate) was given before CSEA
    Intervention: Drug: Ringer's Lactate
  • Active Comparator: Posterior crystalloid
    Crystalloid (Ringer's Lactate) was given after CSEA
    Intervention: Drug: Ringer's Lactate
  • Active Comparator: Prior colloid
    Colloid (6% hydroxyethyl starch) was given before CSEA
    Intervention: Drug: Six percent hydroxyethyl starch
  • Active Comparator: Posterior colloid
    Colloid (6% hydroxyethyl starch) was given after CSEA
    Intervention: Drug: Six percent hydroxyethyl starch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
850
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
21 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00973414
NJMU-09053MZ
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP