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

Seoul National University

Status: Not yet enrolling

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

Treatments: Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume; Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

Study type: Interventional

Funder types: Other

Identifiers

NCT05490147

2206-069-1332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

Experimental group

Description:

In the conventional tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 10\~12 throughout the surgery.

Treatment:

Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

Experimental group

Description:

In the low tidal volume group, patients are ventilated with a tidal volume \[ml\]= ideal body weight \[kg\]\* 6\~8 throughout the surgery.

Treatment:

Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume