Prediction of the Recovery of Neuromuscular Transmission After Curarization

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550664
• Other study ID #: CHUB-NMB recovery
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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