Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose
Condition: Muscle Relaxant; General Anesthesia
MeSH terms: Muscle Hypotonia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular
      blockade of rocuronium
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study
      and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid,
      non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on
      the subjects in the operation room. After preoxygenation was given with 100% oxygen, general
      anesthesia induction was done with midazolam 0.01-0.02 mg/kg, fentanyl 3 mcg/kg, propofol 1-2
      mg/kg, and rocuronium 0.6 mg/kg. Following induction, endotracheal intubation or laryngeal
      mask insertion was performed. Maintenance was done by sevoflurane 1.2 vol%, and fentanyl 1.2
      mcg/kg. After the surgery had finished, fentanyl drip was stopped. Subjects were then
      observed until spontaneous breaths occured adequately (tidal volume ≥ 5 ml/kg) before train
      of four (TOF) ratio was evaluated using acceleromyography (AMG). Before reversal
      (neostigmine) was given, anesthetic gas was stopped and duration of operation as well as
      post-operative TOF ratio was recorded. The time since reversal was given then recorded. Group
      A received neostigmine partial dose (0.02 mg) in combination with atropine 0.4 mg for every
      milligram of neostigmine. Group B received TOF ratio-based dose of neostigmine in combination
      with atropine 0.4 mg for every milligram of neostigmine. After administration of neostigmine,
      TOF ratio was measured every 5 minutes until TOF ratio of ≥ 90% was achieved, and finally
      definitive airway could be removed. For Group A, another partial dose of neostigmine was
      given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been
      reached. For Group B, another TOF ratio-based dose of neostigmine was given after 10 minutes
      from the first reversal dose if the TOF ratio of ≥90% had not been reached. Subjects were
      then transported to recovery room. Data was analyzed using Statistical Package for the Social
      Sciences (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for
      categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by
      Kolmogorov-Smirnov test. Significant value is p<0.05.
    

Intervention name(s): Dose of Neostigmine
Intervention type(s): Drug
Intervention description(s): Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished
Other intervention name(s): prostigmin
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care