Hepatic Cancer, Intraoperative Bleeding, Neuromuscular Blockade
Conditions
Keywords
liver surgery, bleeding, neuromuscular blockade, rocuronium, airway pressure
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.
Interventions
PROCEDURENeuromuscular blockade
Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intra-operative blood loss | Postoperative day 0 | total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical revision | Up to hospital discharge, an average of 5 days | incidence of surgical revision |
| Airway peak and plateau pressures | Postoperative day 0 | airway pressures, as indicated by ventilator peak pressure (mmHg) and plateau pressure (mmHg) during surgery |
| Quality of surgical field | Postoperative day 0 | 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 |
| Surgery and hepatic resection time | Postoperative day 0 | surgery and hepatic resection time |
| Number of blood product units transfused | Up to hospital discharge, an average of 5 days | number of blood product units transfused from the experimental intervention until hospital discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| 90-day quality of life | day 90 | quality of life measured with Euro-Quality of Life - 5 Dimensions scale (EQ-5D-5L), composed of: * the EQ-5D-5L descriptive system comprising 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension * the EQ VAS corresponding to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine' |
| Pulmonary complications at day 30 | day 30 | rate of pulmonary complications |
| 30-day mortality | day 30 | mortality |
Countries
Italy
Outcome results
None listed