Blood Loss, Surgical, Hepatocellular Carcinoma, Liver Cirrhosis, Ventilator Lung
Conditions
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.
Interventions
PROCEDUREconventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
In the conventional tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 10\ 12.
PROCEDURElow tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
In the low tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 6\ 8.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
a surgeon blinded randomized controlled study
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | during surgery | amount drained from peritoneal cavity - irrigation fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transfusion amount | op. end ~ postoperative day 3 | RBC, FFP, platelet |
| postoperative hemoglobin level | op. end ~ postoperative day 3 | postoperative hemoglobin |
| postoperative total bilirubin level | op. end ~ postoperative day 3 | postoperative total bilirubin level |
| postoperative PT INR level | op. end ~ postoperative day 3 | postoperative PT INR level |
| postoperative aspartate aminotransferase level | op. end ~ postoperative day 3 | postoperative aspartate aminotransferase level |
| postoperative lung complications | op end ~ postoperative 2 weeks | atelectasis, pneumonia |
| postoperative serum creatinine level | op. end ~ postoperative day 3 | postoperative serum creatinine level |
| operation time | during surgery | operation time |
| amount of crystalloids infused | during surgery | amount of crystalloids infused |
| Satisfaction scale of the operator and participants | during surgery | easy 0 - 10 difficult |
| postoperative alanine aminotransferase level | op. end ~ postoperative day 3 | postoperative alanine aminotransferase level |
Countries
South Korea
Contacts
Primary ContactSeong Mi Yang
Backup ContactHye-Yeon Cho
Outcome results
None listed