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

Poitiers University Hospital

Status: Invitation-only

Conditions: Neuromuscular Blockade

Treatments: Device: Monitorage by TOF/PTC; Device: Monitorage by ATP

Study type: Interventional

Funder types: Other

Identifiers

NCT05784610

CURATP

2022-A01929-34 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups

TOF/PTC

Active Comparator group

Description:

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.

Treatment:

Device: Monitorage by ATP

Device: Monitorage by TOF/PTC

ATP

Experimental group

Description:

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.

Treatment:

Device: Monitorage by ATP