Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ventilator Lung, Liver Cirrhosis, Hepatocellular Carcinoma, Blood Loss, Surgical

Intervention / Treatment
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* Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10 12) group
* Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6 8) volume


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a surgeon blinded randomized controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10 12) group<br>In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10 12 throughout the surgery. | Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10 12) group<br>* In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10 12.<br>|
| Experimental: low tidal (tidal volume [ml]= ideal body weight [kg] * 6 8) volume<br>In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6 8 throughout the surgery. | Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6 8) volume<br>* In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6 8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | amount drained from peritoneal cavity - irrigation fluid | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative lung complications | atelectasis, pneumonia | op end   postoperative 2 weeks | 
| transfusion amount | RBC, FFP, platelet | op. end   postoperative day 3 | 
| postoperative hemoglobin level | postoperative hemoglobin | op. end   postoperative day 3 | 
| postoperative total bilirubin level | postoperative total bilirubin level | op. end   postoperative day 3 | 
| postoperative PT INR level | postoperative PT INR level | op. end   postoperative day 3 | 
| postoperative aspartate aminotransferase level | postoperative aspartate aminotransferase level | op. end   postoperative day 3 | 
| postoperative alanine aminotransferase level | postoperative alanine aminotransferase level | op. end   postoperative day 3 | 
| postoperative serum creatinine level | postoperative serum creatinine level | op. end   postoperative day 3 | 
| operation time | operation time | during surgery | 
| amount of crystalloids infused | amount of crystalloids infused | during surgery | 
| Satisfaction scale of the operator and participants | easy 0 - 10 difficult | during surgery |