Fluid Management for Cesarean Section III

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Registration Number: NCT00973414
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Last Update Submitted: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 850

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prior crystalloid	Ringer's Lactate	Crystalloid (Ringer's Lactate) was given before CSEA
Posterior crystalloid	Ringer's Lactate	Crystalloid (Ringer's Lactate) was given after CSEA
Prior colloid	Six percent hydroxyethyl starch	Colloid (6% hydroxyethyl starch) was given before CSEA
Posterior colloid	Six percent hydroxyethyl starch	Colloid (6% hydroxyethyl starch) was given after CSEA

Primary Outcome Measures

Name	Time	Method
Rate of hypotension	Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China