Patients undergoing non-cardiac surgery under general anesthesia
Conditions
Interventions
Experimental group:Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection
The control group:Succinylated Gelatin Injection
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old, =64 years old, both sexes; 2) Body mass index (BMI) 18-29kg/m2, Hb>100g/L; 3) the estimated operation time is >2h, and the colloid volume is 500-1000ml; 4) American Society of Anesthesiologists (ASA) anesthesia risk Assessment Criteria Grade ? or ?; 5) Patients or their guardians agree to participate in the clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) patients with severe hypernatremia, hyperchloremia, and hypercalcemia: that is, serum sodium > 152mmol/L, or serum calcium >12 mg/dL (>3.00mmol/L), or serum chloride concentration when the value was higher than the normal value of 1.06mmol/L, clinical abnormalities such as drowsiness, coma, insanity and delirium were evaluated. 2) Pulmonary edema, cerebral edema, intracranial hemorrhage and heart failure; 3) Patients with liver and renal function indexes exceeding 2 times the upper limit of the normal range; 4) Previous organic brain disease or cerebral hemorrhage history, organic heart disease or cardiac stent placement, mental disease history and consciousness disorders. 5) Patients with abnormal coagulation function test results and electrolyte test results; 6) Patients who had received dialysis treatment within one month before surgery; 7) Patients judged to lack the ability to give informed consent; 8) Patients who have participated in other drug trials in the last 3 months; 9) Known allergic reactions to the test drug and/or its components (e.g., gelatin plasma substitutes, a-galactose); 10) Patients with previous hypothyroidism; 11) Patients who are pregnant, lactating or trying to become pregnant; 12) Patients undergoing neurosurgery; 13) Any patient judged by the investigator to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Betweengroup differences in the change in base surplus (BE) from baseline at 15min after drug infusion;Intergroup difference in the change of chloride (Cl-) from baseline at 15min after the end of drug infusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Betweengroup differences in the change in base surplus (BE) from baseline at 24h after the end of surgery;Group difference in the change of chloride (Cl-) from baseline at 24h after surgery;Hemodynamic changes (SBP, DBP, MAP, HR);Blood gas analysis (pH,HCO3-, SatO2);Liquid dosage; | — |
Countries
China
Contacts
Public ContactHanyu Yang
Outcome results
None listed