Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

Study Overview
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Brief Summary
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Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy.

Detailed Description
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The study was a single-center prospective randomized controlled study. A total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: Group A, sodium bicarbonate Ringer's solution group(n=50); Group B, Lactate Ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); Collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (T0), during liver specimens resected(T1), after liver specimens resected(T2), and the end of surgery (T3). Then statistical analysis and observe the application prospect of sodium bicarbonate Ringer's injection in Laparoscopic hepatectomy.

Official Title
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The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy

Conditions
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Hepatic Ischemia

Intervention / Treatment
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* Drug: sodium bicarbonate Ringer's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old, patients who plan to undergoing laparoscopic hepatectomy ; Willing to sign informed consent. Exclusion Criteria: age <18 years pregnancy active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) history of significant cerebrovascular disease restrictive or obstructive pulmonary disease uncontrolled hypertension renal dysfunction (glomerular filtration rate <60 mL/min), evidence of hepatic metabolic disorder (bilirubin >35 mmol/L) presence of active infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Sodium bicarbonate Ringer's solution group | Drug: sodium bicarbonate Ringer's solution<br>* Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.<br>* Other names: lactated Ringer's solution;|
| Active Comparator: Group B<br>Lactate Ringer's solution group | Drug: sodium bicarbonate Ringer's solution<br>* Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.<br>* Other names: lactated Ringer's solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactic values | to compare the conditions of acid-base balance and internal environment between the two groups | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sodium bicarbonate injection (ml) |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month. | 
| Value of pH |  | From the start of operation until the end of operation (during the operation). | 
| Concentration of HCO3- |  | From the start of operation until the end of operation (during the operation). | 
| Value of BE |  | From the start of operation until the end of operation (during the operation). | 
| Concentration of Glucose |  | From the start of operation until the end of operation (during the operation). | 
| Value of MAP |  | From the start of operation until the end of operation (during the operation). | 
| Value of HR |  | From the start of operation until the end of operation (during the operation). | 
| Concentration of CI |  | From the start of operation until the end of operation (during the operation). | 
| Value of SVV |  | From the start of operation until the end of operation (during the operation). | 
| Value of SVR |  | From the start of operation until the end of operation (during the operation). | 
| Value of PPV |  | From the start of operation until the end of operation (during the operation). | 
| Amount of norepinephrine |  | From the start of operation until the end of operation (during the operation). | 
| Amount of phenylephrine |  | From the start of operation until the end of operation (during the operation). | 
| Amount of ephedrine |  | From the start of operation until the end of operation (during the operation). | 
| Amount of nitroglycerin |  | From the start of operation until the end of operation (during the operation). | 
| Amount of milrinone |  | From the start of operation until the end of operation (during the operation). | 
| Amount of furosemide |  | From the start of operation until the end of operation (during the operation). | 
| time of palinesthesia from general anesthsia | postoperative palinesthesia, recovering time | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month. | 
| time of stay in PACU |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month. | 
| extubation time |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month. | 
| Concentration of BUN |  | day 1 and day 3 after surgery. | 
| Concentration of Cr |  | day 1 and day 3 after surgery. | 
| Value of AST |  | day 1 and day 3 after surgery. | 
| Value of ALT |  | day 1 and day 3 after surgery. | 
| Amount of blood loss | amount of blood loss during the operation. | intraoperative | 
| Amount of blood transfusion | amount of blood transfusion during the operation. | intraoperative | 
| urinary output | amount of urinary output during the operation. | intraoperative | 
| 15-item quality of recovery scale scores (QoR-15) | 15-item quality of recovery scale scores. the minimum value is 0 and maximum value is 150, and whether higher scores mean a better outcome. | day 1 and day 3 after surgery. |