Fluid Management for Cesarean Section III (FMCS-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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • The Affiliated Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: HES/HAES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Duration of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia
Low umbilical cord pH (artery < 7.20)	At the time of successful delivery (0 min)

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 9, 2009
• Last Update Submitted That Met QC Criteria: September 8, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Fluid therapy; Combined epidural spinal anesthesia
• Other Study ID Numbers: NJMU-09053MZ