Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05830136

Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium bicarbonate Ringer's solution

Drug

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.

Other names: lactated Ringer's solution

Primary outcomes

  1. 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

  1. 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.

  2. Value of pH

    Time frame: From the start of operation until the end of operation (during the operation).

  3. Concentration of HCO3-

    Time frame: From the start of operation until the end of operation (during the operation).

  4. Value of BE

    Time frame: From the start of operation until the end of operation (during the operation).

  5. Concentration of Glucose

    Time frame: From the start of operation until the end of operation (during the operation).

  6. Value of MAP

    Time frame: From the start of operation until the end of operation (during the operation).

  7. Value of HR

    Time frame: From the start of operation until the end of operation (during the operation).

  8. Concentration of CI

    Time frame: From the start of operation until the end of operation (during the operation).

  9. Value of SVV

    Time frame: From the start of operation until the end of operation (during the operation).

  10. Value of SVR

    Time frame: From the start of operation until the end of operation (during the operation).

  11. Value of PPV

    Time frame: From the start of operation until the end of operation (during the operation).

  12. Amount of norepinephrine

    Time frame: From the start of operation until the end of operation (during the operation).

  13. Amount of phenylephrine

    Time frame: From the start of operation until the end of operation (during the operation).

  14. Amount of ephedrine

    Time frame: From the start of operation until the end of operation (during the operation).

  15. Amount of nitroglycerin

    Time frame: From the start of operation until the end of operation (during the operation).

  16. Amount of milrinone

    Time frame: From the start of operation until the end of operation (during the operation).

  17. Amount of furosemide

    Time frame: From the start of operation until the end of operation (during the operation).

  18. time of palinesthesia from general anesthsia

    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.

    postoperative palinesthesia, recovering time

  19. time of stay in PACU

    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.

  20. extubation time

    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.

  21. Concentration of BUN

    Time frame: day 1 and day 3 after surgery.

  22. Concentration of Cr

    Time frame: day 1 and day 3 after surgery.

  23. Value of AST

    Time frame: day 1 and day 3 after surgery.

  24. Value of ALT

    Time frame: day 1 and day 3 after surgery.

  25. Amount of blood loss

    Time frame: intraoperative

    amount of blood loss during the operation.

  26. Amount of blood transfusion

    Time frame: intraoperative

    amount of blood transfusion during the operation.

  27. urinary output

    Time frame: intraoperative

    amount of urinary output during the operation.

  28. 15-item quality of recovery scale scores (QoR-15)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shijiang Liu

CONTACT

[email protected]

02568303569

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.