Clinical trial NCT04609410: Bleeding in Laparoscopic Liver Surgery
Official title: Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Blockade
Intraoperative Bleeding
Hepatic Cancer
Keywords: liver surgery
bleeding
neuromuscular blockade
rocuronium
airway pressure
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total intra-operative blood loss
timeFrame: Postoperative day 0
Secondary outcomes:
measure: Number of blood product units transfused
timeFrame: Up to hospital discharge, an average of 5 days
measure: Incidence of surgical revision
timeFrame: Up to hospital discharge, an average of 5 days
measure: Airway peak and plateau pressures
timeFrame: Postoperative day 0
measure: Quality of surgical field
timeFrame: Postoperative day 0
measure: Surgery and hepatic resection time
timeFrame: Postoperative day 0
Other outcomes:
measure: 30-day mortality
timeFrame: day 30
measure: Pulmonary complications at day 30
timeFrame: day 30
measure: 90-day quality of life
timeFrame: day 90
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Alberto Zangrillo, Prof.
role: STUDY_DIRECTOR
affiliation: IRCCS San Raffaele Scientific Institute
name: Luigi Beretta, Prof.
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele Scientific Institute
name: Raffaella Reineke, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, Lingg C, Geisler M, Fink H. Neuromuscular blockade improves surgical conditions (NISCO). Surg Endosc. 2015 Mar;29(3):627-36. doi: 10.1007/s00464-014-3711-7. Epub 2014 Aug 15.
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