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NCT Number: NCT01013090

Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia

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.

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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

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
  • With contradictions of neuraxial anesthesia

Treatment and study plan

Ringer's Lactate

Drug

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 names: Lactated Ringer's solution

Six percent hydroxyethyl starch

Drug

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 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. Duration of hypotension

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

  4. Oxygen saturation during hypotension

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

  5. One-min and 5-min Apgar scores

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

  6. 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 Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia

Acronym: VOHOCUNA

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2009
Registry last updated
Dec 23, 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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