Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

Neuromuscular Monitoring Clinical Trial

— TOFScan  

Official title:

Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880787
• Other study ID #: 2014-A00540-47
• Status: Recruiting
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 23, 2016
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Thomas FUCHS-BUDER, Pr
• Email: t.fuchs-buder[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.

Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:

• the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value

• the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value

• recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)

• complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

Adult population:

• Non opposition to research

• > 18 years old

• ASA score 1-3

• Undergoing surgery with curarisation through tracheal intubation

• Affiliation to social security

Pediatric population:

• > 1 year old

• Non opposition to research of child (if able to consent) or representatives with parental authority

• ASA score 1-4

• Undergoing surgery with curarisation

• Affiliation to social security

Exclusion Criteria:

Adult population:

• Allergy to administered drugs

• Known or suspected difficult intubation

• Pregnant women

• BMI > 40

Pediatric population:

• Allergy to administered drugs

• Known or suspected difficult intubation

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Curarisation
• Neuromuscular Monitoring

Intervention

Drug:
• Rocuronium
Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)

Device:
• Neuromuscular monitoring with TOFScan® and TOF-Watch SX®
Each monitor on one arm

Locations

Country	Name	City	State
France	CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Primary	Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Secondary	Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No
Secondary	Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX		day 0, after induction of anesthesia	No