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

NCT ID: NCT05490147

Condition: Ventilator Lung
Liver Cirrhosis
Hepatocellular Carcinoma
Blood Loss, Surgical

Conditions: Official terms:
Liver Cirrhosis
Blood Loss, Surgical

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: a surgeon blinded randomized controlled study

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
Description: In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12.
Arm group label: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

Intervention type: Procedure
Intervention name: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Description: In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8.
Arm group label: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

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.

Criteria for 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

Gender: All

Minimum age: 19 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Country: Korea, Republic of

Start date: August 8, 2022

Completion date: August 8, 2023

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05490147

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