Clinical Trial: Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose

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

Detailed Summary: 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
Sponsor: Indonesia University

Current Primary Outcome:

  • TOF ratio with partial dose of neostigmine [ Time Frame: Day 1 ]
    Train-of-Four ratio obtained from post-operative acceleromyography after the first partial dose of neostigmine had been administrated until definitive airway device can be removed
  • TOF ratio with TOF ratio-based dose of neostigmine [ Time Frame: Day 1 ]
  • TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine [ Time Frame: Day 1 ]
  • time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine [ Time Frame: Day 1 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indonesia University

Dates:
Date Received: February 12, 2017
Date Started: October 2016
Date Completion: February 2017
Last Updated: February 15, 2017
Last Verified: February 2017