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

NCT05053594 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-09-22

No results posted yet for this study

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.

Conditions

  • Neuromuscular Blockade
  • Neuromuscular Block, Residual
  • Neuromuscular Block Prolonged

Interventions

DRUG

Neostigmine 10 mcg/kg

Once the third response to TOF is obtained, neostigmine 10 mcg/kg will be administered

DRUG

Neostigmine 20 mcg/kg

Once the third response to TOF is obtained, neostigmine 20 mcg/kg will be administered

DRUG

Neostigmine 30 mcg/kg

Once the third response to TOF is obtained, neostigmine 30 mcg/kg will be administered

OTHER

Placebo

Once the third response to TOF is obtained, saline will be administered

Sponsors & Collaborators

  • Pontificia Universidade Catolica de Sao Paulo

    lead OTHER

Principal Investigators

  • Eduardo T Moro, MD · Pontificia Catholic University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-02-01
Completion
2022-02-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053594 on ClinicalTrials.gov