Clinical trial NCT05490147: Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Lung
Liver Cirrhosis
Hepatocellular Carcinoma
Blood Loss, Surgical
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a surgeon blinded randomized controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: during surgery
Secondary outcomes:
measure: postoperative lung complications
timeFrame: op end ~ postoperative 2 weeks
measure: transfusion amount
timeFrame: op. end ~ postoperative day 3
measure: postoperative hemoglobin level
timeFrame: op. end ~ postoperative day 3
measure: postoperative total bilirubin level
timeFrame: op. end ~ postoperative day 3
measure: postoperative PT INR level
timeFrame: op. end ~ postoperative day 3
measure: postoperative aspartate aminotransferase level
timeFrame: op. end ~ postoperative day 3
measure: postoperative alanine aminotransferase level
timeFrame: op. end ~ postoperative day 3
measure: postoperative serum creatinine level
timeFrame: op. end ~ postoperative day 3
measure: operation time
timeFrame: during surgery
measure: amount of crystalloids infused
timeFrame: during surgery
measure: Satisfaction scale of the operator and participants
timeFrame: during surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seong Mi Yang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hendi M, Lv J, Cai XJ. Current status of laparoscopic hepatectomy for the treatment of hepatocellular carcinoma: A systematic literature review. Medicine (Baltimore). 2021 Dec 17;100(50):e27826. doi: 10.1097/MD.0000000000027826.
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