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

March 13, 2023 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Centre Hospitalier de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TOF/PTC
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
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
Other Names:
  • Installation of TOFscan®
Device: Monitorage by ATP
Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists
Other Names:
  • Installation of TOFscan®
Experimental: 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 ATP mode on one of the patient's wrists
Other Names:
  • Installation of TOFscan®

What is the study measuring?

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
Time Frame: From intubation to surgical closure
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
Time Frame: 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
From intubation to surgical closure
Amount of NMB agents administered
Time Frame: From intubation to surgical closure
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
Time Frame: From intubation to surgical closure
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
Time Frame: From intubation to surgical closure
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
Time Frame: 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"
From intubation to surgical closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: MATTHIEU M BOISSON, Professor, University Center Hospital of Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CURATP
  • 2022-A01929-34 (Registry Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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