Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

Nanjing Medical University

Status: Enrolling

Conditions: Hepatic Ischemia

Treatments: Drug: sodium bicarbonate Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05830136

2021-SR-386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Sodium bicarbonate Ringer's solution group

Treatment:

Drug: sodium bicarbonate Ringer's solution

Group B

Active Comparator group

Description:

Lactate Ringer's solution group

Treatment:

Drug: sodium bicarbonate Ringer's solution