Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Liver Neoplasms

Blood Loss, Surgical

Intraoperative Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Hematinics

Rocuronium

Liver Extracts

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.

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.

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

Neuromuscular blockade

Giovanni Landoni, Prof.

Giovanni Landoni, Prof

Luigi Beretta, Prof.

Alberto Zangrillo, Prof.

Roberta Meroni, MD

Matteo Marzaroli, MD

Raffaella Reineke, MD

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.

Bleeding in Laparoscopic Liver Surgery

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

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'

total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister

number of blood product units transfused from the experimental intervention until hospital discharge

airway pressures, as indicated by ventilator peak pressure (mmHg) and plateau pressure (mmHg) during surgery

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

Università Vita-Salute San Raffaele

MD, Associate Professor

Eye Diseases

Heart and Blood Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nutritional and Metabolic Diseases

Rare Diseases

Neoplasm Metastasis

Diabetic Retinopathy

Retinal Detachment

Retinal Diseases

Vitreous Hemorrhage

Conversion Disorder

Dissociative Disorders

Neoplastic Processes

Diabetic Angiopathies

Vascular Diseases

Diabetes Mellitus

Diabetes Complications

Endocrine System Diseases

Mental Disorders

Psychotic Disorders

Antineoplastic Agents

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Pharmaceutical Solutions

Anti-Infective Agents

Blood Substitutes

Micronutrients

Bevacizumab

Lidocaine

Povidone-Iodine

Povidone

Iodine

Cadexomer iodine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Intravitreal bevacizumab Small-gauge pars plana vitrectomy

A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.

Intravitreal bevacizumab

Small-gauge pars plana vitrectomy

The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy \[TSV\]). In addition, post-operative rebleeding may be decreased.

This will be a prospective, randomized, active-controlled study of 224 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 1:1 ratio to the study arm.

1. Control arm: PPV without pre-operative bevacizumab (Sham injection).
2. Study arm: Pre-operative bevacizumab (3-5 days) before PPV.

In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS).

The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.

Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group

We would now like to examine molecules in the vitreous humor and epiretinal membranes to gain insight and better assess the efficacy and outcomes of pre-operative intravitreal bevacizumab.

Early (\<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)

Mean change in best-corrected visual acuity (BCVA) at 12 months

Pan American Collaborative Retina Study Group

J. Fernando Arevalo, MD FACS

Chief of Vitreoretina Division

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bleeding in Laparoscopic Liver Surgery	NCT04609410	Neuromuscular B... Intraoperative ... Hepatic Cancer	Neuromuscular b...	18 Years -	Università Vita-Salute San Raffaele
Bleeding in Laparoscopic Liver Surgery	NCT04609410	Neuromuscular B... Intraoperative ... Hepatic Cancer	Neuromuscular b...	18 Years -	Università Vita-Salute San Raffaele
Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy	NCT01976923	Tractional Reti...	Intravitreal be... Small-gauge par...	18 Years -	King Khaled Eye Specialist Hospital

Spots Global Cancer Trial Database for intraoperative bleeding