Neuromuscular Blockade
Conditions
Keywords
deep neuromuscular blockade, neuromuscular blockade monitoring, automated management, abdominal surgery, laparoscopy
Brief summary
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
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.
Interventions
DEVICEMonitorage by TOF/PTC
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
DEVICEMonitorage by ATP
Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists
Sponsors
Poitiers University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Masking only for the anesthesist in arms Time 1
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From intubation to surgical closure | Percentage of time spent on deep NMB target during anesthesia, defined by PTC ≥ 1 and ≤ 5 responses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of interventions by the anesthesia team to maintain deep curarization | From intubation to surgical closure | Number of NMB agents reinjections and interventions on the NMB monitor by the anesthesia team, per hour, during the procedure |
| Amount of NMB agents administered | From intubation to surgical closure | Total dose of NMB agents administered in mg/kg/h during the surgical procedure |
| Need to reverse NMB agents at the end of the procedure | From intubation to surgical closure | Number of patients requiring NMB reversal with prostigmine or sugammadex |
| Effect of maintaining deep NMB at surgical level during the procedure | From intubation to surgical closure | Maximum intra-abdominal pressure of insufflation in mmHg recorded during surgical procedure |
| Surgical conditions on the Leiden Surgical Rating Scale score | From intubation to surgical closure | 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 |
Countries
France
Outcome results
None listed