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The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethyl starch (130/0.4) coload group | Experimental | An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyethyl starch 130/0.4 | Drug | An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 100 ml according to the responses of previous patients according to the up-down sequential allocation. |
| Measure | Description | Time Frame |
|---|---|---|
| ED 50 and ED 90 | The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients | 1-15 minutes after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-15 minutes after spinal anesthesia |
| The incidence of severe post-spinal anesthesia hypotension. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Chen, M.D. | Contact | 86-951-674-3252 | czzyxgp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Chen, M.D. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750004 | China |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D003102 | Colloids |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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|
|
Systolic blood pressure (SBP) < 60% of the baseline.
| 1-15 minutes after spinal anesthesia |
| The incidence of bradycardia. | Heart rate < 60 beats/min. | 1-15 minutes after spinal anesthesia |
| The incidence of nausea and vomiting. | Presence of nausea and vomiting in patients after spinal anesthesia | 1-15 minutes after spinal anesthesia |
| The incidence of hypertension. | Systolic blood pressure (SBP) >120% of the baseline. | 1-15 minutes after spinal anesthesia |
| pH | From umbilical arterial blood gases. | Immediately after delivery |
| Partial pressure of oxygen (PO2) | From umbilical arterial blood gases. | Immediately after delivery |
| Base excess (BE) | From umbilical arterial blood gases. | Immediately after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 min after delivery |
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 min after delivery |
| D011134 |
| Polysaccharides |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |