Prediction of the Recovery of Neuromuscular Transmission After Curarization

NCT ID: NCT03550664

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2020-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Surgical intervention

Patients undergoing a surgical intervention within the CHU Brugmann with utilisation of rocuronium.

Group Type EXPERIMENTAL

Monitoring of neuromuscular transmission

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Head of the Anesthesiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis Schmartz, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 29365307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26087274 (View on PubMed)

Related Links

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Other Identifiers

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CHUB-NMB recovery

Identifier Type: -

Identifier Source: org_study_id

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