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| ID | Type | Description | Link |
|---|---|---|---|
| NJFY09331M041 | Other Grant/Funding Number | Nanjing Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural crystalloid | Active Comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section |
|
| Epidural colloid | Active Comparator | Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section |
|
| Spinal crystalloid | Active Comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section |
|
| Spinal colloid | Active Comparator | Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section |
|
| CSEA crystalloid | Active Comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Lactate | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hypotension | Anesthesia begin (0 min) to 120 min after anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of hypotension after ephedrine or phenylephrine | Anesthesia begin (0 min) to 120 min after anesthesia | |
| Consumption of ephedrine and phenylephrine | Anesthesia begin (0 min) to 120 min after anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XiaoFeng Shen, MD | Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| CSEA colloid |
| Active Comparator |
Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section |
|
|
| Six percent hydroxyethyl starch | Drug | 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 |
|
|
| 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 |
| 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) |