A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery
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.
• Age range is 18 to 65 years old (including boundary values), with no gender restrictions.
• Weight not less than 50 kg, weight not more than 100 kg, body mass index \[BMI=weight (kg)/height 2 (m2)\] within the range of 19.0\
• 0 kg/m2 (including critical values).
• Planned elective surgery with an estimated duration of less than 6 hours.
• The expected ANH blood collection volume is 10% to 15% of the total blood volume.
• Prior to enrollment, the Hb level of the subjects was ≥ 110 g/L.
• The American Society of Anesthesiologists (ASA) has a rating of I-III.
• Voluntarily participate in this experiment and sign a written informed consent form.