Bleeding in Laparoscopic Liver Surgery

Not Applicable

Recruiting

• Conditions: Intraoperative Bleeding; Hepatic Cancer; Neuromuscular Blockade
• Interventions: Procedure: Neuromuscular blockade

• Registration Number: NCT04609410
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-25
• Study Start: 2020-10-30
• Study First Posted: 2020-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular blockade	Neuromuscular blockade	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.
Moderate neuromuscular blockade	Neuromuscular blockade	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Airway peak and plateau pressures	Postoperative day 0	airway pressures, as indicated by ventilator peak pressure (mmHg) and plateau pressure (mmHg) during surgery
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
Surgery and hepatic resection time	Postoperative day 0	surgery and hepatic resection time
Incidence of surgical revision	Up to hospital discharge, an average of 5 days	incidence of surgical revision
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

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milano, Italy