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

Not Applicable

• Conditions: Curarisation; Neuromuscular Monitoring
• Interventions: Drug: Rocuronium; Device: Neuromuscular monitoring with TOFScan® and TOF-Watch SX®

• Registration Number: NCT02880787
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult population 1	Neuromuscular monitoring with TOFScan® and TOF-Watch SX®	TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Adult population 2	Neuromuscular monitoring with TOFScan® and TOF-Watch SX®	TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Pediatric population 1	Neuromuscular monitoring with TOFScan® and TOF-Watch SX®	TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Pediatric population 2	Neuromuscular monitoring with TOFScan® and TOF-Watch SX®	TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Adult population 1	Rocuronium	TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Adult population 2	Rocuronium	TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
Pediatric population 1	Rocuronium	TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
Pediatric population 2	Rocuronium	TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation; 🇫🇷 Vandoeuvre Les Nancy, France