Neuromuscular BlockadeMODELSNCT04609410
Bleeding in Laparoscopic Liver Surgery
A study testing Neuromuscular blockade in people with Neuromuscular Blockade and Intraoperative Bleeding, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Intraoperative Bleeding, Hepatic Cancer
- What is being tested?
- Neuromuscular blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2020to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic liver resection
- Patients ≥ 18 years old
- Patients willing to participate to the study and able to validly sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery
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.
- Being tested
- Neuromuscular blockade
- Keywords
- liver surgery, bleeding, neuromuscular blockade, rocuronium, airway pressure
- Medical subject headings
- Blood Loss, Surgical, Liver Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular blockadeProcedure or surgery
Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular blockade | Experimental | 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. Receives: Procedure: Neuromuscular blockade |
| Moderate neuromuscular blockade | Active comparator | 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. Receives: Procedure: Neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intra-operative blood loss
total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister
Measured: Postoperative day 0
Secondary outcomes (5)
Number of blood product units transfused
number of blood product units transfused from the experimental intervention until hospital discharge
Measured: Up to hospital discharge, an average of 5 days
Incidence of surgical revision
incidence of surgical revision
Measured: 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
Measured: 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
Measured: Postoperative day 0
Surgery and hepatic resection time
surgery and hepatic resection time
Measured: Postoperative day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start30 Oct 2020
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Why it stopped: Resources not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
- Investigators
- Alberto Zangrillo, Prof., Study director, IRCCS San Raffaele Scientific InstituteLuigi Beretta, Prof., Study chair, IRCCS San Raffaele Scientific InstituteRaffaella Reineke, MD, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609410
- Sponsor's protocol ID
- MODELS/22/OSR
- Acronym
- MODELS
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16721773Taketomi 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.
PubMed 17382216Yang 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.
PubMed 21656309Moggia 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.
PubMed 27797116Honda 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.
PubMed 23269462Kobayashi 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.
PubMed 26595124Blobner 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.
PubMed 25125097Oh 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.
PubMed 31013693
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery
- ClinicalTrials.gov ID
- NCT04609410
- Acronym / sponsor ID
- MODELS / MODELS/22/OSR
- Keywords
- liver surgery, bleeding, neuromuscular blockade, rocuronium, airway pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources not available
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Procedure: Neuromuscular blockadeDuring 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 | Active comparator | Procedure: Neuromuscular blockadeDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic liver resection
- Patients ≥ 18 years old
- Patients willing to participate to the study and able to validly sign informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular blockadeNeuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring | Procedure or surgery | Deep neuromuscular blockade, Moderate neuromuscular blockade |
Primary outcome
Total intra-operative blood loss
Time frame: Postoperative day 0
total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister
5 secondary outcomes
Number of blood product units transfused
Time frame: Up to hospital discharge, an average of 5 days
Incidence of surgical revision
Time frame: Up to hospital discharge, an average of 5 days
Airway peak and plateau pressures
Time frame: Postoperative day 0
Quality of surgical field
Time frame: Postoperative day 0
Surgery and hepatic resection time
Time frame: Postoperative day 0
Results and safety
The study was stopped early (reason given: Resources not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 16721773Ibrahim 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.
- Background: PubMed 17382216Taketomi 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.
- Background: PubMed 21656309Yang 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.
- Background: PubMed 27797116Moggia 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.
- Background: PubMed 23269462Honda 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.
- Background: PubMed 26595124Kobayashi 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.
- Background: PubMed 25125097Blobner 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.
- Background: PubMed 31013693Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Zangrillo, Prof. study director
IRCCS San Raffaele Scientific Institute
Luigi Beretta, Prof. study chair
IRCCS San Raffaele Scientific Institute
Raffaella Reineke, MD principal investigator
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular blockade in people with Neuromuscular Blockade and Intraoperative Bleeding, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resources not available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intra-operative blood loss (time frame: Postoperative day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609410, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.