Cesarean Section Clinical Trial
— FMCS-IIIOfficial title:
Fluid Management for Cesarean Section Undergoing Combined Spinal Epidural Anesthesia (CSEA)
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing Medical University |
China,
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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