Bleeding in Laparoscopic Liver Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Neuromuscular Blockade, Intraoperative Bleeding, Hepatic Cancer

Intervention / Treatment
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* Procedure: Neuromuscular blockade


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep neuromuscular blockade<br>During surgery, deep neuromuscular blockade will be achieved with the use of train of four (TOF) monitoring, aiming for a Post-Tetanic Count (PTC) = 0 or PTC = 1 and Train of Four Count (TOFC) = 0. TOF and PTC measurements will be performed every 15 minutes. Boluses of 0,1 mg/kg Rocuronium will be administered if monitored PTC is > 1. Complete neuromuscular blockade reversal at the end of surgery will be achieved with an i.v. bolus of Sugammadex (variable dose according to depth of residual blockade) if TOF ratio is ≤ 0.9. If TOF ratio is > 0.9, pharmacological neuromuscular blockade reversal can be avoided. | Procedure: Neuromuscular blockade<br>* Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring<br>|
| Active Comparator: Moderate neuromuscular blockade<br>During surgery, a moderate neuromuscular blockade will be achieved with the use of train of four (TOF) monitoring. TOF and Post-Tetanic Count (PTC) measurements will be performed every 15 minutes. Boluses of 0,1 mg/kg Rocuronium will be administered if monitored TOF count is ≥ 1 and/or PTC > 5. Complete neuromuscular blockade reversal at the end of surgery will be achieved with an i.v. bolus of Sugammadex (variable dose according to depth of residual blockade) if TOF ratio is ≤ 0.9. If TOF ratio is > 0.9, pharmacological neuromuscular blockade reversal can be avoided. | Procedure: Neuromuscular blockade<br>* Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intra-operative blood loss | total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister | Postoperative day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood product units transfused | number of blood product units transfused from the experimental intervention until hospital discharge | Up to hospital discharge, an average of 5 days | 
| Incidence of surgical revision | incidence of surgical revision | Up to hospital discharge, an average of 5 days | 
| Airway peak and plateau pressures | airway pressures, as indicated by ventilator peak pressure (mmHg) and plateau pressure (mmHg) during surgery | Postoperative day 0 | 
| Quality of surgical field | quality of surgical field as assessed by the surgeon with Leiden-Surgical Rating Scale (L-SRS), ranging from 1 (extremely poor conditions) to 5 (optimal conditions), higher scores meaning better outcome | Postoperative day 0 | 
| Surgery and hepatic resection time | surgery and hepatic resection time | Postoperative day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver surgery, bleeding, neuromuscular blockade, rocuronium, airway pressure