Reducing bleeding during laparoscopic liver surgery
Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery
This study is testing if a special type of muscle relaxation during liver surgery can help reduce bleeding for adults having laparoscopic liver surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT04609410 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of deep neuromuscular blockade to minimize intraoperative bleeding during laparoscopic liver resection surgeries. By reducing airway pressures, the study aims to lower central venous pressure, which is associated with decreased bleeding from the hepatic veins. Patients aged 18 and older who are undergoing this type of surgery will be included, while those with certain pre-existing conditions will be excluded. The study is conducted at Ospedale San Raffaele in Milan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for laparoscopic liver resection.
Not a fit: Patients with low platelet counts, active bleeding, or those requiring continuous neuromuscular blockade monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce blood loss during liver surgeries, improving patient outcomes and recovery times.
How similar studies have performed: While the specific approach of using deep neuromuscular blockade in laparoscopic liver surgery is novel, similar techniques have shown promise in reducing bleeding in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milano
- Ospedale San Raffaele — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Raffaella Reineke, MD — IRCCS San Raffaele Scientific Institute
- Study coordinator: Giovanni Landoni, Prof.
- Email: landoni.giovanni@hsr.it
- Phone: +39022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.