Clinical Trials Directory

Trials / Terminated

TerminatedNCT04609410

Bleeding in Laparoscopic Liver Surgery

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Università Vita-Salute San Raffaele · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENeuromuscular blockadeNeuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring

Timeline

Start date
2020-10-30
Primary completion
2023-09-20
Completion
2023-09-20
First posted
2020-10-30
Last updated
2025-08-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04609410. Inclusion in this directory is not an endorsement.