Comparison of Two Neuromuscular Monitors

Neuromuscular Monitoring Clinical Trial

— NMT-STIMPOD  

Official title:

Comparison of Two Neuromuscular Monitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350062
• Other study ID #: 13-183
• Status: Completed
• Phase: N/A
• First received: November 27, 2014
• Last updated: January 28, 2015
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Exclusion Criteria:

• Pregnancy or feeding

• Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation

• American Society of Anesthesiology [4] physical status

• Allergy or contraindication of neuromuscular blocking agents

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuromuscular Monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recover T4/T1 > 90%	After muscle relaxant injection, we measure the time needed for the muscular response to disappear and to completely recover during the operation (which takes in average 2 hours).	Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours	No