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Clinical Trials/NCT05490147
NCT05490147
Unknown
Not Applicable

Effect of Low Tidal Volume Ventilation Strategy Combined Goal -Directed Fluid Therapy on Intraoperative Bleeding Undergoing Laparoscopic Major Hepatectomy in Liver Cancer Patients: a Surgeon Blinded Randomized Controlled Study

Seoul National University Hospital1 site in 1 country58 target enrollmentAugust 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator Lung
Sponsor
Seoul National University Hospital
Enrollment
58
Locations
1
Primary Endpoint
Intraoperative blood loss
Last Updated
3 years ago

Overview

Brief Summary

This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.

Detailed Description

Patients are randomized into the conventional tidal volume (tidal volume \[ml\]= ideal body weight \[kg\]\* 10\~12) group and low tidal (tidal volume \[ml\]= ideal body weight \[kg\] \* 6\~8) volume group and ventilated accordingly throughout the surgery. All patients undergo general anesthesia with propofol, remifentanil, and rocuronium and are intubated with an endotracheal tube (ID 7.0 for females, ID 7.5 for males). Anesthesia is maintained with sevoflurane, end tidal CO2 is targeted between 30-35mmHg. The radial artery is cannulated and connected to the Flotrac sensor and goal directed fluid therapy is done. The estimated blood loss is checked as the primary outcome. In addition postoperative complications, transfusion amounts, operation time, satisfaction of the surgeon and participants are also recorded.

Registry
clinicaltrials.gov
Start Date
August 8, 2022
End Date
August 8, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments

Exclusion Criteria

  • ASA class \>4
  • patients with chronic obstructive pulmonary disease
  • patients with Child-Pugh score C
  • patients with arrythmia

Outcomes

Primary Outcomes

Intraoperative blood loss

Time Frame: during surgery

amount drained from peritoneal cavity - irrigation fluid

Secondary Outcomes

  • Satisfaction scale of the operator and participants(during surgery)
  • transfusion amount(op. end ~ postoperative day 3)
  • postoperative alanine aminotransferase level(op. end ~ postoperative day 3)
  • postoperative lung complications(op end ~ postoperative 2 weeks)
  • postoperative hemoglobin level(op. end ~ postoperative day 3)
  • postoperative total bilirubin level(op. end ~ postoperative day 3)
  • postoperative PT INR level(op. end ~ postoperative day 3)
  • operation time(during surgery)
  • postoperative aspartate aminotransferase level(op. end ~ postoperative day 3)
  • postoperative serum creatinine level(op. end ~ postoperative day 3)
  • amount of crystalloids infused(during surgery)

Study Sites (1)

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