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Spots Global Cancer Trial Database for Bleeding in Laparoscopic Liver Surgery

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Trial Identification

Brief Title: Bleeding in Laparoscopic Liver Surgery

Official Title: Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery

Study ID: NCT04609410

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ospedale San Raffaele, Milano, , Italy

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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