Clinical trial NCT05830136: Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy
Official title: The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Ischemia
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old,
2. patients who plan to undergoing laparoscopic hepatectomy ;
3. Willing to sign informed consent.

Exclusion Criteria:

1. age \<18 years
2. pregnancy
3. active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
4. history of significant cerebrovascular disease
5. restrictive or obstructive pulmonary disease
6. uncontrolled hypertension
7. renal dysfunction (glomerular filtration rate \<60 mL/min),
8. evidence of hepatic metabolic disorder (bilirubin \>35 mmol/L)
9. presence of active infection

Primary outcomes:
measure: lactic values
timeFrame: 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 outcomes:
measure: Amount of sodium bicarbonate injection (ml)
timeFrame: 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.
measure: Value of pH
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Concentration of HCO3-
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of BE
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Concentration of Glucose
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of MAP
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of HR
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Concentration of CI
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of SVV
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of SVR
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Value of PPV
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of norepinephrine
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of phenylephrine
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of ephedrine
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of nitroglycerin
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of milrinone
timeFrame: From the start of operation until the end of operation (during the operation).
measure: Amount of furosemide
timeFrame: From the start of operation until the end of operation (during the operation).
measure: time of palinesthesia from general anesthsia
timeFrame: 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.
measure: time of stay in PACU
timeFrame: 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.
measure: extubation time
timeFrame: 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.
measure: Concentration of BUN
timeFrame: day 1 and day 3 after surgery.
measure: Concentration of Cr
timeFrame: day 1 and day 3 after surgery.
measure: Value of AST
timeFrame: day 1 and day 3 after surgery.
measure: Value of ALT
timeFrame: day 1 and day 3 after surgery.
measure: Amount of blood loss
timeFrame: intraoperative
measure: Amount of blood transfusion
timeFrame: intraoperative
measure: urinary output
timeFrame: intraoperative
measure: 15-item quality of recovery scale scores (QoR-15)
timeFrame: day 1 and day 3 after surgery.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Shijiang Liu
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shijiang Liu
role: PRINCIPAL_INVESTIGATOR
References: