Different Doses of Neostigmine for Reversal of Moderate Neuromuscular Blockade in Children

• Status: Not yet recruiting
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

There is no recent information on the required dose of neostigmine for the reversal of cisatracurium-induced moderate neuromuscular blockade (NMB) [Train-of-four (TOF) count = 1-3)] in children. The aim of this study will be to evaluate by means of a prospective, randomized and double-blinded clinical trial, the time required for reversal of moderate NMB (TOFc 3) to T4/T1 (TOF ratio, TOFr) > 0.9 and TOFr = 1.0 after administration of different doses of neostigmine (10, 20 or 30 mcg/kg) or placebo in children undergoing inhalational (sevoflurane) general anesthesia. In addition, the probability of NMB reversal in less than 10 minutes, the presence of bradycardia, respiratory complications and postoperative vomiting will be evaluated. The time for reversal is expected to be inversely proportional to the administered dose of neostigmine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pontificia Universidade Catolica de Sao Paulo
• Treatments: Neostigmine

Criteria

Inclusion Criteria:

• Children physical status according to the American Society of Anesthesiologists I and II

• Submitted to general anesthesia to perform tonsillectomy associated or not with adenoidectomy

Exclusion Criteria:

• Refusal to participate in the study

• Presence of kidney, liver or neuromuscular disease

• Contraindication to the use of any drug used in the study

• Body mass index (BMI) ≥ 30.