Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia
- Conditions
- Cesarean Section
- Interventions
- Drug: Ringer's LactateDrug: Six percent hydroxyethyl starch
- Registration Number
- NCT01013090
- Lead Sponsor
- Nanjing Medical University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1000
- 21-40 yr
- First time of delivery
- ASA status I-II
- No premature
- No genetic and infectious diseases
- Chinese
- < 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSEA crystalloid Ringer's Lactate Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section Spinal crystalloid Ringer's Lactate Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section Epidural colloid Six percent hydroxyethyl starch Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section Epidural crystalloid Ringer's Lactate Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section CSEA colloid Six percent hydroxyethyl starch Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section Spinal colloid Six percent hydroxyethyl starch Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section
- Primary Outcome Measures
Name Time Method Rate of hypotension Anesthesia begin (0 min) to 120 min after anesthesia
- Secondary Outcome Measures
Name Time Method Consumption of ephedrine and phenylephrine Anesthesia begin (0 min) to 120 min after anesthesia Duration of hypotension Anesthesia begin (0 min) to 120 min after anesthesia Oxygen saturation during hypotension Anesthesia begin (0 min) to 120 min after anesthesia Recurrence of hypotension after ephedrine or phenylephrine Anesthesia begin (0 min) to 120 min after anesthesia One-min and 5-min Apgar scores The first and fifth minute after cesarean successful delivery Low umbilical cord pH (artery < 7.20) At the time of successful delivery (0 min)
Trial Locations
- Locations (1)
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, Jiangsu, China