Bleeding in Laparoscopic Liver Surgery (MODELS)

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    200
  • sponsor
    Università Vita-Salute San Raffaele
Updated on 9 July 2022

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.

Details
Condition Neuromuscular Blockade, Intraoperative Bleeding, Hepatic Cancer
Treatment Neuromuscular blockade
Clinical Study IdentifierNCT04609410
SponsorUniversità Vita-Salute San Raffaele
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients undergoing laparoscopic liver resection
Patients ≥ 18 years old
Patients willing to participate to the study and able to validly sign informed consent

Exclusion Criteria

Patients presenting a pre-operative platelet count < 50 x 109/L and/or patients with active pre-operative bleeding
Patients with planned requirement of continuous neuromuscular blockade monitoring (upon clinical judgement)
Known hypersensitivity / previous allergic reactions to study medications
Planned total intra-venous anesthesia technique
Pregnant or breastfeeding patients
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