Prediction of the Recovery of Neuromuscular Transmission After Curarization

NCT03550664 | Completed

• 1 other identifier: CHUB-NMB recovery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Surgical intervention

EXPERIMENTAL

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

Device: Monitoring of neuromuscular transmission

Interventions

Monitoring of neuromuscular transmission 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.

Surgical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy towards rocuronium
• \< 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (2)

• 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.

  PMID: 29365307 BACKGROUND

• 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.

  PMID: 26087274 BACKGROUND

Related Links

• Related Info

Study Officials

• Denis Schmartz, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Anesthesiology department

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 8, 2018
• Study Start: June 12, 2018
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)