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The succinylated gelatin electrolyte sodium acetate injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical. is used as the experimental drug, and the succinylated gelatin electrolyte sodium acetate injection (trade name: Jialeban) produced and licensed by Braun Medical (Suzhou) Co., Ltd ®; Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental grou | Experimental |
| |
| control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| succinylated gelatin electrolyte sodium acetate injection 1 | Drug | Nanjing Chia-Tai Tianqing Pharmaceutical Company |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH | 5 minutes after the completion of ANH compared to immediately before the start of ANH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yumeng zhou | Contact | 86-025-85109999 | yumeng_zhou@163.com |
| Name | Affiliation | Role |
|---|---|---|
| wen ouyang | The Third Xiangya Hospital of Central South University | Principal Investigator |
| saiying wang | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| succinylated gelatin electrolyte sodium acetate injection | Drug | Gelaspan |
|