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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


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
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