Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sodium bicarbonate Ringer's solution.
- Who it may be relevant to
- Registry conditions: Hepatic Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy
Overview
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
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.
Interventions
- Drug sodium bicarbonate Ringer's solution
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.
Primary outcome measures
- lactic values [Time frame: 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 (12)
- Amount of sodium bicarbonate injection (ml) [Time frame: 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 [Time frame: From the start of operation until the end of operation (during the operation).]
- Concentration of HCO3- [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of BE [Time frame: From the start of operation until the end of operation (during the operation).]
- Concentration of Glucose [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of MAP [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of HR [Time frame: From the start of operation until the end of operation (during the operation).]
- Concentration of CI [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of SVV [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of SVR [Time frame: From the start of operation until the end of operation (during the operation).]
- Value of PPV [Time frame: From the start of operation until the end of operation (during the operation).]
- Amount of norepinephrine [Time frame: From the start of operation until the end of operation (during the operation).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shijiang Liu — Nanjing
Identifiers
NCT: NCT05830136 · 2021-SR-386