Prediction of the Recovery of Neuromuscular Transmission After Curarization

Prediction of the Recovery of Neuromuscular Transmission After Curarization, Pilot Study

The vast majority of patients receive neuromuscular blockers during surgical procedures, either as a single injection to facilitate intubation or as repeated injections to induce muscle relaxation necessary for surgery. The action of neuromuscular blockers is monitored by measuring the contraction force of the adductor of the thumb after stimulation of the ulnar nerve.Different types of stimulation, such as train-of-four (TOF), post- Tetanus count (PTC), double-burst stimulation (DBS) measure different degrees of curarization.The duration of action of neuromuscular blockers has significant interindividual variability. If the investigators know how to measure the degree of curarization of a patient at a given time, it is difficult to know how long it will take to recover neuromuscular function.

The purpose of this study is to determine if the individual recovery of a patient can be predicted form data obtained at the beginning of his/her recovery curve. The investigators propose to record all neuromuscular transmission monitoring data in 100 patients. From these data, the investigators will try to develop an algorithm that would extrapolate the recovery curve of an isolated patient from the fist neuromuscular monitoring data.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Device: Monitoring of neuromuscular transmission

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

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 undergoing a surgical intervention with rocuronium
• Patients covered by the Belgian social security system

Exclusion Criteria:

• Allergy towards rocuronium
• 20< Body Mass Index <30
• Hepatocellular insufficiency, either clinical or abnormal liver tests
• Renal insufficiency, defined as Modification of diet in renal disease (MDRD) <40ml / min or Cockgroft <50ml / min
• Need to antagonize the curare

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Surgical intervention; Patients undergoing a surgical intervention within the CHU Brugmann with utilisation of rocuronium.

Device: Monitoring of neuromuscular transmission; Monitoring of neuromuscular transmission will be done by TOFScan (IdMed, Marseille, France). This device is CE marked, and is used routinely in daily clinical practice. Prior to induction of anesthesia, the TOFScan is placed on a patient's hand and the two stimulation electrodes (ECG electrodes) are placed at the level of the ulnar nerve at the wrist. After induction of anesthesia and before administration of a curare, the TOFScan is calibrated according to the manufacturer's instructions. The TOFScan is placed in automatic mode, it will then automatically adapt its mode of stimulation to the depth of the curarization. The TOFScan measurements will be recorded on a PC connected to the TOFScan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOFScan recording	Recordings of the TOFScan device (monitoring of the neuro-muscular transmission) during the entire length of the surgery are automatically stored on PC. This data will be used to conceive a mathematical algorithm predicting the decurarisation curve of an individual patient.	1 day

Collaborators and Investigators

• Sponsor: Brugmann University Hospital

Publications and helpful links

General Publications

• Ortega R, Brull SJ, Prielipp R, Gutierrez A, De La Cruz R, Conley CM. Monitoring Neuromuscular Function. N Engl J Med. 2018 Jan 25;378(4):e6. doi: 10.1056/NEJMvcm1603741. No abstract available.
• Heerdt PM, Sunaga H, Savarese JJ. Novel neuromuscular blocking drugs and antagonists. Curr Opin Anaesthesiol. 2015 Aug;28(4):403-10. doi: 10.1097/ACO.0000000000000209.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2018
• Primary Completion (ACTUAL): June 20, 2020
• Study Completion (ACTUAL): June 20, 2020

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CHUB-NMB recovery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No