Skip to content

A randomized, open, parallel controlled, multicenter investigator-initiated clinical study of the clinical effect of compound sodium acetate and glucose injection on perioperative rehabilitation of patients undergoing lower abdominal surgery under general anesthesia

A randomized, open, parallel controlled, multicenter investigator-initiated clinical study of the clinical effect of compound sodium acetate and glucose injection on perioperative rehabilitation of patients undergoing lower abdominal surgery under general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100564
Enrollment
Unknown
Registered
2025-04-10
Start date
2024-07-23
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Control group:The patient was given an infusion of 500ml of compound sodium lactate glucose injection (30 to 60 minutes after the infusion)
After the operation, 500ml of compound sodium lactate glucose injection was infused (30 to 60 minutes after the infusion).
Research group:The patient was given an infusion of 500ml of compound sodium acetate glucose injection (30 to 60 minutes after the infusion)
After the operation, 500ml of compound sodium acetate glucose injection was infused (30 to 60 minutes after the infusion).

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who plan to undergo abdominal surgery under general anesthesia and need intestinal preparation according to preoperative requirements; 2.18 < age < 65 years old, gender is not limited; 3. The subjects fully understand the purpose and significance of the study, voluntarily participate in the study, voluntarily sign the informed consent letter, and voluntarily abide by the process of the study. The informed consent is signed by the subjects themselves or authorized clients.

Exclusion criteria

Exclusion criteria: 1.Patients with a history or current serious clinical illness of any of the following conditions that the investigator determined affected the study: (1) diabetes mellitus; (2) Chronic adrenal hypofunction; (3) Severe burns;( 4) hyperazotemia; (5) Abnormal parathyroid function; (6) Patients with cardiac insufficiency (class III-I according to the New York Heart Association [NYHA] classification); 2. Patients who are allergic to or have special reactions to either compound sodium acetate and glucose injection or compound sodium lactate and glucose injection; 3. Those whose laboratory test results met the following criteria during the screening period: 1) Serum potassium > 5.0mmol/L; 2) Serum phosphorus > 1.61mmol/L; 3) Serum calcium 1.25mmol/L; 5) Liver function (ALT, AST, ALP) > 2 times the upper limit of normal; 6) Renal function (urea, Cr) > 2 times the upper limit of normal; 4. Pregnant or lactating women who have sperm donation or fertility plans during the study period or 30 days after the end of the study and are unwilling or unable to take effective contraceptive measures; 5. The investigator assesses that the patient will not be able to complete the study as required or is not suitable to participate in the study for other reasons; 6. Participants who have participated in drug or device clinical studies within 3 months before randomization and have received drug or device treatment, or plan to participate in other clinical investigators during the study period; 7. Patients who have had nasogastric tube or nasojejunal tube placed before surgery, and need to have nasogastric tube or nasojejunal tube placed during or after surgery.

Design outcomes

Primary

MeasureTime frame
EQ-5D-5L Health scale score;

Secondary

MeasureTime frame
Changes in biochemical markers (electrolytes, liver function, renal function, blood glucose);Changes in pH, PaCO?, HCO??, BE (Base Excess), and lactate;Time of first flatus and defecation after surgery; Time of water intake, resumption of liquid diet, and normal diet; Length of hospital stay.;The usage of medications such as insulin, potassium chloride injection, and sodium bicarbonate injection during surgery; The volume of intravenous fluids administered during surgery;

Countries

China

Contacts

Public ContactXia Jiangyan

Zhongda Hospital Southeast University

zhongdacq524@126.com+86 138 1380 6217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026