Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia

Cesarean Section Clinical Trial

— VOHOCUNA  

Official title:

Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013090
• Other study ID #: NMU-200911-MZ020
• Secondary ID: NJFY09331M041
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: December 22, 2009
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2009
• Est. primary completion date: December 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

• With contradictions of neuraxial anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension

Intervention

Drug:
• Ringer's Lactate
Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
• Six percent hydroxyethyl starch
Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks

Locations

Country	Name	City	State
China	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	Duration of hypotension		Anesthesia begin (0 min) to 120 min after anesthesia	Yes
Secondary	Oxygen saturation during hypotension		Anesthesia begin (0 min) 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	Low umbilical cord pH (artery < 7.20)		At the time of successful delivery (0 min)	Yes