Comparision of Different Dose of Neostigmine at Advanced Decurarization
Condition: Anesthesia
Intervention: neostigmine; neostigmine; neostigmine
Intervention description: 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
Intervention MeSH terms: Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: neostigmine; neuromuscular blocking agent; train of four; anesthesia

Summary:

      Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to
      NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is
      monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a
      mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in
      clinical routine. Acceleromyography is the most currently monitoring available in daily
      practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is
      necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to
      perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG
      TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with
      neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes
      parasympathomimetic effects which has to be reversed with atropine. When neuromuscular
      blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the
      visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side
      effects expected. The goal of the study is to compare the delay between a light neuromuscular
      block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02,
      0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient > 18 years

          -  informed consent signed

          -  Patient undergoing any type of scheduled surgery under general anesthesia for which
             curarization with eventually a maintenance is indicated

          -  ASA score between I to III

        Exclusion Criteria:

          -  patient > 75 years and < 18 years

          -  body mass index > 32 mg/m²

          -  neurology disease, neuromuscular or muscular disease

          -  peripheral neuropathy

          -  coronary heart disease

          -  asthma

          -  familial history of malign hyperthermia

          -  difficulty of intubation and ventilation

          -  full stomach

          -  known or suspected allergy to one of the study drug

          -  mecanique obstruction of digestive or urinary tract

          -  open-angle glaucoma

          -  patient with risk of urinary retention linked to urethra-prostatic disorder

          -  concomittant medication with a influence known on neuromuscular (aminosid,
             anti-convulsif and corticosteroid

          -  child bearing women or nursing mother

          -  no affiliation at a social security