Trial intelligence / Profile preview

Neostigmine for Reversal of Cisatracurium-Induced Neuromuscular Blockade

NCT04920682Phase 4

Key facts

Status: Completed
Start: Jun 2021
Primary completion: Aug 2021
Countries: 1
Sponsor: Pontifícia Universidade Católica de São Paulo
Modality: Small Molecules

Drugs: neostigmine
Conditions: neuromuscular blockade (NMB)

Overview

Phase 4, randomised, double-blind trial of neostigmine in neuromuscular blockade (NMB) (4 arms), sponsored by Pontifícia Universidade Católica de São Paulo. Primary endpoint: Time for the T4/T1 ratio to reach 1.0 up to 2 hours. Started Jun 2021; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Moderate Block Reversal
High dose neostigmine at moderate block level.
Superficial Block Reversal
Low dose neostigmine at superficial block level.
Two-Step Reversal
Split dose neostigmine at both moderate and superficial levels.
Placebo Control
Saline administration at both levels.

Who it enrols

Patients aged 18-65, ASA I-II, undergoing nose and ear surgery with a BMI < 30 and no history of kidney, liver, or neuromuscular disease.

Endpoints

Primary

Time for the T4/T1 ratio to reach 1.0up to 2 hours

Secondary

Probability of reversing the neuromuscular blockade in less than 10 minutes10 minutes

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