CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
neostigmine +2 moredrug
Likely dose
neostigmine 0.04 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00847938
NCT00847938Phase 3Completed

Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

Centre Hospitalier Departemental Vendee·interventional·Posted Feb 19, 2009·Updated May 29, 2019

In Brief

A Phase 3 clinical trial evaluating neostigmine for Anesthesia. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago

Interventions

neostigminedrug

0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

neostigminedrug

0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

neostigminedrug

0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %