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Brief Title: Bleeding in Laparoscopic Liver Surgery
Official Title: Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery
Study ID: NCT04609410
Brief Summary: Blood loss during liver resection surgery affects patients morbidity, short and long-term mortality. Among non-surgical interventions to minimize intraoperative blood loss and perioperative blood products transfusion, maintaining conditions of low central venous pressure is considered as standard of care. In animals undergoing laparoscopic hepatectomy, reducing airway pressures represents a minimally invasive measure to reduce central venous pressure and therefore bleeding from the hepatic vein. Neuromuscular blocking agents are usually administered during anesthesia to facilitate endotracheal intubation and to improve surgical conditions: a deep level of neuromuscular blockade has already been shown to reduce peak airway pressures and plateau airway pressures in non-abdominal procedures. Such airway pressures reduction can potentially limit bleeding from hepatic veins during transection phase in liver surgery. The aim of the present study is to evaluate the impact of deep neuromuscular blockade on bleeding (as a consequence of reduced airway peak pressure and plateau pressure) in hepatic laparoscopic resections. Patients undergoing laparoscopic liver resection will be randomized to achieve, using intravenous Rocuronium, either a deep neuromuscular blockade (post-tetanic count = 0 and/or = 1 and train of four count = 0) or moderate neuromuscular blockade (train of four count ≥ 1 and/or post-tetanic count \> 5) during surgery. Neuromuscular blockade measurements will be performed every 15 minutes. The primary endpoint is to assess the total blood loss at the end of the resection phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ospedale San Raffaele, Milano, , Italy
Name: Alberto Zangrillo, Prof.
Affiliation: IRCCS San Raffaele Scientific Institute
Role: STUDY_DIRECTOR
Name: Luigi Beretta, Prof.
Affiliation: IRCCS San Raffaele Scientific Institute
Role: STUDY_CHAIR
Name: Raffaella Reineke, MD
Affiliation: IRCCS San Raffaele Scientific Institute
Role: PRINCIPAL_INVESTIGATOR