Clinical trial NCT05784610: Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring (CURATP)
Official title: Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring : A Pilot Pre-post Quasi Experimental Study (CURATP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: deep neuromuscular blockade
neuromuscular blockade monitoring
automated management
abdominal surgery
laparoscopy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From intubation to surgical closure
Secondary outcomes:
measure: Number of interventions by the anesthesia team to maintain deep curarization
timeFrame: From intubation to surgical closure
measure: Amount of NMB agents administered
timeFrame: From intubation to surgical closure
measure: Need to reverse NMB agents at the end of the procedure
timeFrame: From intubation to surgical closure
measure: Effect of maintaining deep NMB at surgical level during the procedure
timeFrame: From intubation to surgical closure
measure: Surgical conditions on the Leiden Surgical Rating Scale score
timeFrame: From intubation to surgical closure
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier de Poitiers
state: Vienne
Study officials:
affiliation: University Center Hospital of Poitiers
name: MATTHIEU M BOISSON, Professor
role: PRINCIPAL_INVESTIGATOR
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