Fluid Management for Cesarean Section II (FMCS-II)

Fluid Management for Cesarean Section Undergoing Spinal Anesthesia

Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 860
• 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 spinal anesthesia	Drug: Ringer's Lactate; Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section; Other Names: Lactated Ringer's solution
Active Comparator: Posterior crystalloid; Crystalloid (Ringer's Lactate) was given after spinal anesthesia	Drug: Ringer's Lactate; Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section; Other Names: Lactated Ringer's solution
Active Comparator: Prior colloid; Colloid (6% hydroxyethyl starch) was given before spinal anesthesia	Drug: Six percent hydroxyethyl starch; Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section; Other Names: HES/HAES
Active Comparator: Posterior colloid; Colloid (6% hydroxyethyl starch) was given after spinal anesthesia	Drug: Six percent hydroxyethyl starch; Hydroxyethyl starch (6%) was given before or after spinal anesthesia 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
• Collaborators: Nanjing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 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: Spinal anesthesia; Fluid therapy
• Other Study ID Numbers: NJMU-08711MZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No