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Reversal of Moderate or Superficial Neuromuscular Blockade Induced by Cisatracurium

NCT04920682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-19

No results posted yet for this study

Summary

The administration of acetylcholinesterase inhibiting agents (such as neostigmine) has been used to reverse the muscle paralysis induced by non-depolarizing neuromuscular blocking agents. It is not well known whether there is a difference between the time required for complete reversion of moderate neuromuscular blockade (NMB) after the administration of neostigmine in usual doses when compared to the reversion of superficial NMB with the use of a reduced dose of the same agent (excessive doses of neostigmine administered during superficial blocks may cause paradoxical muscle weakness). The aim of the present study will be to compare, by means of a prospective, randomized, controlled and double-blind clinical trial, the times necessary for the reversion of moderate block with neostigmine 60 mcg / kg or for superficial block to reach values of T4 / T1\> 0.9 using neostigmine 30 mcg / kg.

Conditions

  • Neostigmine
  • Neuromuscular Blocking Agents
  • Muscle Weakness

Interventions

DRUG

Reversal of moderate neuromuscular blockade

Neostigmine 60 mcg/kg when TOF (Train-of-Four) = 3 and saline when TOF (T4 / T1)\> 0.4

DRUG

Reversal of superficial neuromuscular blockade

Neostigmine 30 mcg/kg when TOF (T4 / T1)\> 0.4

DRUG

Two-step reversal

Neostigmine 30 mcg/kg when TOF = 3 and neostigmine 30 mcg/kg when TOF (T4 / T1)\> 0.4

DRUG

Placebo

0.9% saline solution (SF) when TOF = 3 and when TOF (T4 / T1)\> 0.4

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
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-08-01
Completion
2021-08-21

Countries

  • Brazil

Study Locations

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Entities

Drugs

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 NCT04920682 on ClinicalTrials.gov