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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00973414
Other study ID # NJMU-09053MZ
Secondary ID
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


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
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