An interventional study of Monitorage by TOF/PTC and Monitorage by ATP in Neuromuscular Blockade, sponsored by Poitiers University Hospital. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: Monitorage by ATP
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
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
Also known as: Installation of TOFscan®
Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists
Also known as: Installation of TOFscan®
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
Time frame: From intubation to surgical closure
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
Time frame: From intubation to surgical closure
Amount of NMB agents administered
Total dose of NMB agents administered in mg/kg/h during the surgical procedure
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: From intubation to surgical closure
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Poitiers University Hospital