Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring (CURATP)

Study Overview
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Brief Summary
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Neuromuscular blockade (NMB) recommendations updated in 2018 by the Société Française d'Anesthésie et Réanimation (SFAR) recommend the use of NMB agents to facilitate surgical procedure during abdominal surgery by laparotomy or laparoscopy. This study aims to evaluate deep NMB monitoring with automated management of NMB depth measurement (ATP mode) versus non-automated monitoring (PTC/TOF), in order to improve the maintenance of deep NMB during abdominal surgery.

Detailed Description
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The beneficial effects of deep NMB on the surgical conditions and thus the per and post operative surgical morbidity have been demonstrated in several studies, but the evidence are not yet consistent enough to make recommendations. The monitoring of per operative NMB remains the rule, using the Train Of Four (TOF) at the ulnar nerve at the adductor of the thumb. However, when deep NMB for the most resistant muscles of the body is required (diaphragm and abdominal wall), the Post Tetanic Count (PTC) should be used. In order to better adjust the NMB to the conditions of muscle relaxation required during surgery, an automatic mode called ATP for Automatic TOF/PTC has been developed (TofScan, Idmed, Marseille, France). The investigators hypothesized that the use of the ATP would be able to better insure deep NMB, and to limit interventions on patients and/or on the NMB monitor during surgical procedure.

Official Title
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Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring : A Pilot Pre-post Quasi Experimental Study (CURATP)

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Device: Monitorage by TOF/PTC
* Device: Monitorage by ATP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included if they meet all the following criteria : Age ≥ 18 years Scheduled Abdominal surgery by laparoscopy (digestive, urological and gynaecological) with a planned procedure duration of more than one hour, requiring deep NMB by rocuronium ASA I, II or III Free subject, without guardianship, curatorship or subordination Signed informed consent Exclusion Criteria: Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection. Induction in rapid sequence, Use of an other NMB agent than rocuronium Predictable difficult intubation Persons participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Time 1: Non-automated neuromuscular blockade monitoring (TOF/PTC). As the NMB monitoring is depending on anesthesiologist usual practice and so only TOF measure is systematic, it is necessary to include a blind anesthesiologist measurement with the ATP mode in order to compare with data obtained during Time 2. Time 2: Automated neuromuscular blockade monitoring (ATP). TOF and PTC stimulations are regularly performed, and PTC is systematically performed if TOF = 0/4
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOF/PTC<br>Non-automated neuromuscular blockade monitoring (TOF/PTC). As the NMB monitoring is depending on anesthesiologist usual practice and so only TOF measure is systematic, it is necessary to include a blind anesthesiologist measurement with the ATP mode in order to compare with data obtained during Time 2. | Device: Monitorage by TOF/PTC<br>* Installation of TOFscan® and monitoring by MAR appreciation on one of the patient's wrists and installation of TOFscan® and monitoring by ATP mode (MAR blind) on the other wrist Installation of TOFscan® and monitoring by ATP mode<br>* Other names: Installation of TOFscan®;Device: Monitorage by ATP<br>* Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists<br>* Other names: Installation of TOFscan®;|
| Experimental: ATP<br>Automated neuromuscular blockade monitoring (ATP). TOF and PTC stimulations are regularly performed, and PTC is systematically performed if TOF = 0/4. If PTC = 10/10, a TOF stimulation is automatically performed. | Device: Monitorage by ATP<br>* Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists<br>* Other names: Installation of TOFscan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the monitoring of deep NMB by automated management of the measurement of depth NMB (ATP mode) compared to non-automated monitoring (PTC/TOF) in order to improve the maintenance of deep NMB during abdominal surgery | Percentage of time spent on deep NMB target during anesthesia, defined by PTC ≥ 1 and ≤ 5 responses | From intubation to surgical closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of interventions by the anesthesia team to maintain deep curarization | Number of NMB agents reinjections and interventions on the NMB monitor by the anesthesia team, per hour, during the procedure | From intubation to surgical closure | 
| Amount of NMB agents administered | Total dose of NMB agents administered in mg/kg/h during the surgical procedure | From intubation to surgical closure | 
| Need to reverse NMB agents at the end of the procedure | Number of patients requiring NMB reversal with prostigmine or sugammadex | From intubation to surgical closure | 
| Effect of maintaining deep NMB at surgical level during the procedure | Maximum intra-abdominal pressure of insufflation in mmHg recorded during surgical procedure | From intubation to surgical closure | 
| Surgical conditions on the Leiden Surgical Rating Scale score | Surgical conditions will be measured using a translated French version of the Leiden Surgical Rating Scale ( L-SRS ), a likert scale from 1 extremely poor conditions to 5 optimal conditions | From intubation to surgical closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, deep neuromuscular blockade, neuromuscular blockade monitoring, automated management, abdominal surgery