Bleeding in Laparoscopic Liver Surgery

Neuromuscular Blockade Clinical Trial

— MODELS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609410
• Other study ID #: MODELS/22/OSR
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Giovanni Landoni, Prof.
• Phone: +39022643
• Email: landoni.giovanni[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hepatic Cancer
• Intraoperative Bleeding
• Liver Neoplasms
• Neuromuscular Blockade

Intervention

Procedure:
• Neuromuscular blockade
Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

Honda G, Kurata M, Okuda Y, Kobayashi S, Tadano S, Yamaguchi T, Matsumoto H, Nakano D, Takahashi K. Totally laparoscopic hepatectomy exposing the major vessels. J Hepatobiliary Pancreat Sci. 2013 Apr;20(4):435-40. doi: 10.1007/s00534-012-0586-7. — View Citation

Ibrahim S, Chen CL, Lin CC, Yang CH, Wang CC, Wang SH, Liu YW, Yong CC, Concejero A, Jawan B, Cheng YF. Intraoperative blood loss is a risk factor for complications in donors after living donor hepatectomy. Liver Transpl. 2006 Jun;12(6):950-7. doi: 10.1002/lt.20746. — View Citation

Kobayashi S, Honda G, Kurata M, Tadano S, Sakamoto K, Okuda Y, Abe K. An Experimental Study on the Relationship Among Airway Pressure, Pneumoperitoneum Pressure, and Central Venous Pressure in Pure Laparoscopic Hepatectomy. Ann Surg. 2016 Jun;263(6):1159-63. doi: 10.1097/SLA.0000000000001482. — View Citation

Moggia E, Rouse B, Simillis C, Li T, Vaughan J, Davidson BR, Gurusamy KS. Methods to decrease blood loss during liver resection: a network meta-analysis. Cochrane Database Syst Rev. 2016 Oct 31;10(10):CD010683. doi: 10.1002/14651858.CD010683.pub3. — View Citation

Oh SK, Kwon WK, Park S, Ji SG, Kim JH, Park YK, Lee SY, Lim BG. Comparison of Operating Conditions, Postoperative Pain and Recovery, and Overall Satisfaction of Surgeons with Deep vs. No Neuromuscular Blockade for Spinal Surgery under General Anesthesia: A Prospective Randomized Controlled Trial. J Clin Med. 2019 Apr 12;8(4):498. doi: 10.3390/jcm8040498. — View Citation

Taketomi A, Kitagawa D, Itoh S, Harimoto N, Yamashita Y, Gion T, Shirabe K, Shimada M, Maehara Y. Trends in morbidity and mortality after hepatic resection for hepatocellular carcinoma: an institute's experience with 625 patients. J Am Coll Surg. 2007 Apr;204(4):580-7. doi: 10.1016/j.jamcollsurg.2007.01.035. — View Citation

Yang T, Zhang J, Lu JH, Yang GS, Wu MC, Yu WF. Risk factors influencing postoperative outcomes of major hepatic resection of hepatocellular carcinoma for patients with underlying liver diseases. World J Surg. 2011 Sep;35(9):2073-82. doi: 10.1007/s00268-011-1161-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day mortality	mortality	day 30
Other	Pulmonary complications at day 30	rate of pulmonary complications	day 30
Other	90-day quality of life	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'	day 90
Primary	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	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
Secondary	Incidence of surgical revision	incidence of surgical revision	Up to hospital discharge, an average of 5 days
Secondary	Airway peak and plateau pressures	airway pressures, as indicated by ventilator peak pressure (mmHg) and plateau pressure (mmHg) during surgery	Postoperative day 0
Secondary	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
Secondary	Surgery and hepatic resection time	surgery and hepatic resection time	Postoperative day 0