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Completed

NCT Number: NCT00973414

Fluid Management for Cesarean Section III

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.

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Key information

Conditions

Cesarean Section

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ringer's Lactate

Drug

Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section

Other names: Lactated Ringer's solution

Six percent hydroxyethyl starch

Drug

Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section

Other names: HES/HAES

Primary outcomes

  1. Rate of hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

Secondary outcomes

  1. Recurrence of hypotension after ephedrine or phenylephrine

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  2. Consumption of ephedrine and phenylephrine

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  3. Total volume of colloid or crystalloid

    Time frame: Fifteen minutes before anesthesia to 120 min after anesthesia

  4. One-min and 5-min Apgar scores

    Time frame: The first and fifth minute after cesarean successful delivery

  5. Oxygen saturation during hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  6. Duration of hypotension

    Time frame: Anesthesia begin (0 min) to 120 min after anesthesia

  7. Low umbilical cord pH (artery < 7.20)

    Time frame: At the time of successful delivery (0 min)

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)

Acronym: FMCS-III

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2009
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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