The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- lactic values
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old,
- •patients who plan to undergoing laparoscopic hepatectomy ;
- •Willing to sign informed consent.
Exclusion Criteria
- •age <18 years
- •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
Arms & Interventions
Group A
Sodium bicarbonate Ringer's solution group
Intervention: sodium bicarbonate Ringer's solution (Drug)
Group B
Lactate Ringer's solution group
Intervention: sodium bicarbonate Ringer's solution (Drug)
Outcomes
Primary Outcomes
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.
to compare the conditions of acid-base balance and internal environment between the two groups
Secondary Outcomes
- Concentration of BUN(day 1 and day 3 after surgery.)
- 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).)
- Value of pH(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).)
- 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 HR(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).)
- 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.)
- Value of ALT(day 1 and day 3 after surgery.)
- Amount of blood transfusion(intraoperative)
- Amount of furosemide(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).)
- Amount of nitroglycerin(From the start of operation until the end of operation (during the operation).)
- Concentration of Cr(day 1 and day 3 after surgery.)
- 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).)
- 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 PPV(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).)
- time of palinesthesia from general anesthsia(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 AST(day 1 and day 3 after surgery.)
- Amount of blood loss(intraoperative)
- urinary output(intraoperative)
- 15-item quality of recovery scale scores (QoR-15)(day 1 and day 3 after surgery.)
Investigators
Shijiang Liu, MD
Clinical Professor
The First Affiliated Hospital with Nanjing Medical University