Clinical trial NCT02880787: Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
Official title: Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Curarisation
Neuromuscular Monitoring
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 142
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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%.


Eligibility criteria: 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

Primary outcomes:
measure: Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
measure: Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
timeFrame: day 0, after induction of anesthesia
Secondary outcomes:
measure: 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
timeFrame: day 0, after induction of anesthesia
measure: 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
timeFrame: day 0, after induction of anesthesia
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation
Study officials:
affiliation: CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation - VANDOEUVRE LES NANCY - FRANCE
name: Thomas FUCHS-BUDER, Pr
role: PRINCIPAL_INVESTIGATOR
References: