NCT00973414

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

September 8, 2009

Last Update Submit

September 8, 2009

Conditions

Cesarean Section

Keywords

Combined epidural spinal anesthesiaFluid therapy

Outcome Measures

Primary Outcomes (1)

  • Rate of hypotension

    Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcomes (7)

  • Recurrence of hypotension after ephedrine or phenylephrine

    Anesthesia begin (0 min) to 120 min after anesthesia

  • Consumption of ephedrine and phenylephrine

    Anesthesia begin (0 min) to 120 min after anesthesia

  • Total volume of colloid or crystalloid

    Fifteen minutes before anesthesia to 120 min after anesthesia

  • One-min and 5-min Apgar scores

    The first and fifth minute after cesarean successful delivery

  • Oxygen saturation during hypotension

    Anesthesia begin (0 min) to 120 min after anesthesia

  • +2 more secondary outcomes

Study Arms (4)

Prior crystalloid

ACTIVE COMPARATOR

Crystalloid (Ringer's Lactate) was given before CSEA

Drug: Ringer's Lactate

Posterior crystalloid

ACTIVE COMPARATOR

Crystalloid (Ringer's Lactate) was given after CSEA

Drug: Ringer's Lactate

Prior colloid

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch) was given before CSEA

Drug: Six percent hydroxyethyl starch

Posterior colloid

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch) was given after CSEA

Drug: Six percent hydroxyethyl starch

Interventions

Ringer's LactateDRUG

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

Also known as: Lactated Ringer's solution
Posterior crystalloidPrior crystalloid
Six percent hydroxyethyl starchDRUG

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

Also known as: HES/HAES
Posterior colloidPrior colloid

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases
  • Chinese

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

CN(1)