Curarisation, Neuromuscular Monitoring
Conditions
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%.
Interventions
DRUGRocuronium
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)
DEVICENeuromuscular monitoring with TOFScan® and TOF-Watch SX®
Each monitor on one arm
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactThomas FUCHS-BUDER, Pr
Outcome results
None listed