Fluid Management for Cesarean Section III

Cesarean Section Clinical Trial

— FMCS-III  

Official title:

Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973414
• Other study ID #: NJMU-09053MZ
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Nanjing Bureau of HealthChina: Nanjing Medical University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after CSEA in cesarean section
• Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after CSEA in cesarean section

Locations

Country	Name	City	State
China	The Affiliated Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Recurrence of hypotension after ephedrine or phenylephrine		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Consumption of ephedrine and phenylephrine		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Total volume of colloid or crystalloid		Fifteen minutes before anesthesia to 120 min after anesthesia	Yes
Secondary	One-min and 5-min Apgar scores		The first and fifth minute after cesarean successful delivery	Yes
Secondary	Oxygen saturation during hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Duration of hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Low umbilical cord pH (artery < 7.20)		At the time of successful delivery (0 min)	Yes