Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine
Condition: Postoperative Residual Curarization
MeSH terms: Tetanus; Delayed Emergence from Anesthesia
Study type: Interventional

Summary: 
      Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train
      of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent
      during general anesthesia have a high risk of postoperative pulmonary complications. While
      this train of four ratio threshold is considered as the gold standard to confirm the lack of
      residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been
      observed in absence of reversal agent administration.

      Therefore, the present study has been designed to compare the recovery of train of four
      stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium
      during general anesthesia and reversed by an anticholinesterase agent (neostigmine).
      Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle
      will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with
      the clinical practice worldwide admitted.

      Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow
      a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties
      of neostigmine, does a recurarisation phenomenon occur following repeated tetanus
      stimulations ? The attented results of this study will be to propose a new thinking on what
      we really need to make relevant progress in the safety aspects of residual paralysis outcome.
    


Intervention name(s): TOF scan train of four ratio monitoring; ITF device tetanus stimulation monitoring
Intervention type(s): Device; Device
Intervention description(s): Device : TOF Scan For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. Once 4 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 40 µg/kg neostigmine will be injected. Train of four ratio (delivered every minute) will be recorded. This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 6 times. For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 30 minutes after neostigmine administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.; Device ITF For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. Once 4 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 40 µg/kg neostigmine will be injected. Train of four ratio (delivered every minute) will be recorded. This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 6 times. For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 30 minutes after neostigmine administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other