Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection

Exclusion Criteria

• •1. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.
• •2. Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis), and the researchers have determined that they are not suitable to participate in this trial.
• •3. Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6 months before screening), myocardial infarction (within 6 months before screening), New York Heart Association (NYHA) classification ≥ III, congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placing heart stents or abnormal results of echocardiography and/or 12 lead electrocardiogram during screening, has clinical significance.
• •4. Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such as angiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists and potassium sparing diuretics 10 hours before surgery, and the researchers have determined that they are not suitable to participate in this trial.
• •5. Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\>2 times the upper limit of normal values; Albumin level\<35 g/L; Blood bilirubin is greater than 1.5 times the upper limit of normal value.
• •6. Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\>1.5 times the upper limit of normal values.
• •7. There are any of the following respiratory management risks during screening: 1) history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleep apnea syndrome;
• •8. Hematological disorders such as sickle cell anemia, thalassemia, and pheochromocytoma.
• •9. There is a significant risk of bleeding or coagulation disorders, and the researchers assess that surgery is not suitable, including but not limited to: a) past/current thrombotic or thromboembolic events, or an increased risk of thrombotic or thromboembolic events; b) Require the use of antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) other than aspirin (up to 100 mg/d); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) PT prolongation\>upper limit of normal value of 3 seconds or APTT prolongation\>upper limit of normal value of 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\<80 × 109/L.
• •10. Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and the investigator judged that they were not suitable to participate in the trial.
• •11. History of malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).
• •12. Excessive blood volume (such as polycythemia vera) and fluid overload (such as systemic edema).
• •13. There is an active infection with poor control, which the researchers believe makes the subjects unsuitable to participate in this clinical study.
• •14. Preoperative complications include pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc.
• •15. When screening, there is a water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) and the researcher believes that the abnormality has clinical significance and is not suitable to participate in this clinical study.
• •16. Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.
• •17. Received anemia related treatment, colloidal solution, and/or blood products 14 days before surgery.
• •18. Those who have received the vaccine within one month before surgery.
• •19. Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).
• •20. Has a history of drug abuse in the past.
• •21. Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter).
• •22. Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan or are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine device or condom) during the study period until 1 month after the last use of medication.
• •23. Those who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;
• •24. Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.