A Comparison of Three Different Doses of Neostigmine on the Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade in Patients Under Sevoflurane or TIVA Anesthesia.

METHODS

After the approval of the Research Ethics Committee of the Faculty of Medical and Health Sciences of Pontificia University Catholic of Sao Paulo (PUC-SP), patients submitted to nose or ear surgeries at Santa Lucinda Hospital and able to participate in this clinical, prospective, and randomized trial will be evaluated. The following will be included: patients aged between 18 and 65 years old, physical status according to the American Society of Anesthesiologists I and II, submitted to general anesthesia. Exclusion criteria will be: (i) refusal to participate in the study; (ii) presence of kidney, liver or neuromuscular disease; (iii) contraindication to the use of any of the drugs used in the study or (iv) body mass index (BMI) ≥ 30. Patients will be randomly distributed into one of 6 groups according to the type of anesthesia (inhalational or venous) and the dose of neostigmine used to reverse NMB:

• Group I-30: inhalational anesthesia and reversal with neostigmine 30 mcg/kg and atropine 15 mcg/kg
• Group I-50: inhalational anesthesia and reversal with neostigmine 50 mcg/kg and atropine 25 mcg/kg
• Group I-70: inhalational anesthesia and reversal with neostigmine 70 mcg/kg and atropine 35 mcg/kg
• Group V-30: intravenous anesthesia and reversal with neostigmine 30 mcg/kg and atropine 15 mcg/kg
• Group V-60: intravenous anesthesia and reversal with neostigmine 50 mcg/kg and atropine 25 mcg/kg
• Group V-70: intravenous anesthesia and reversal with neostigmine 70 mcg/kg and atropine 35 mcg/kg.

For each patient, an opaque envelope will be prepared, sealed and numbered sequentially containing the group to which the patient will be allocated. A list of randomized computer-generated numbers (www.random.org) will be used for this purpose. No surgeon, members of the nursing team, anesthesiologist involved in anesthesia or data collection will be aware of the dose of neostigmine to be administered. The type of anesthesia (inhalation or venous) will not be covered. An anesthesiologist not involved in the study will be responsible for preparing the solution containing neostigmine and atropine (diluted with saline solution until complete 20 mL) according to the group to which each patient belongs. Syringes (20 mL) will be similar and identified only with a label with the word "reversal".

STUDY SEQUENCE