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Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

Not Applicable
Recruiting
Conditions
Hepatic Ischemia
Interventions
Drug: sodium bicarbonate Ringer's solution
Registration Number
NCT05830136
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group Asodium bicarbonate Ringer's solutionSodium bicarbonate Ringer's solution group
Group Bsodium bicarbonate Ringer's solutionLactate Ringer's solution group
Primary Outcome Measures
NameTimeMethod
lactic valuesFrom 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 Outcome Measures
NameTimeMethod
Amount of norepinephrineFrom the start of operation until the end of operation (during the operation).
Amount of phenylephrineFrom the start of operation until the end of operation (during the operation).
Value of pHFrom the start of operation until the end of operation (during the operation).
Value of SVRFrom 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 HRFrom the start of operation until the end of operation (during the operation).
Amount of milrinoneFrom the start of operation until the end of operation (during the operation).
time of stay in PACUFrom 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 timeFrom 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 ALTday 1 and day 3 after surgery.
Amount of blood transfusionintraoperative

amount of blood transfusion during the operation.

Amount of furosemideFrom 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 BEFrom the start of operation until the end of operation (during the operation).
Amount of nitroglycerinFrom the start of operation until the end of operation (during the operation).
Concentration of GlucoseFrom the start of operation until the end of operation (during the operation).
Value of MAPFrom the start of operation until the end of operation (during the operation).
Concentration of CIFrom the start of operation until the end of operation (during the operation).
Value of SVVFrom the start of operation until the end of operation (during the operation).
Value of PPVFrom the start of operation until the end of operation (during the operation).
Amount of ephedrineFrom the start of operation until the end of operation (during the operation).
time of palinesthesia from general anesthsiaFrom 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.

postoperative palinesthesia, recovering time

Value of ASTday 1 and day 3 after surgery.
Amount of blood lossintraoperative

amount of blood loss during the operation.

urinary outputintraoperative

amount of urinary output during the operation.

15-item quality of recovery scale scores (QoR-15)day 1 and day 3 after surgery.

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.

Concentration of BUNday 1 and day 3 after surgery.
Concentration of Crday 1 and day 3 after surgery.

Trial Locations

Locations (1)

Shijiang Liu

🇨🇳

Nanjing, Jiangsu, China

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