Comparision of Different Dose of Neostigmine at Advanced Decurarization

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.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHD Vendée

La Roche-sur-Yon, 85925, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient > 18 years
informed consent signed
Patient undergoing any type of scheduled surgery under general anesthesia for which curarization with eventually a maintenance is indicated
ASA score between I to III

Exclusion criteria

patient > 75 years and < 18 years
body mass index > 32 mg/m²
neurology disease, neuromuscular or muscular disease
peripheral neuropathy
coronary heart disease
asthma
familial history of malign hyperthermia
difficulty of intubation and ventilation
full stomach
known or suspected allergy to one of the study drug
mecanique obstruction of digestive or urinary tract
open-angle glaucoma
patient with risk of urinary retention linked to urethra-prostatic disorder
concomittant medication with a influence known on neuromuscular (aminosid, anti-convulsif and corticosteroid
child bearing women or nursing mother
no affiliation at a social security

Treatment and study plan

Neostigmine

Drug

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

Primary outcomes

Mesure of the Train-of-four (TOF)

Time frame: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour

train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: NEODEC

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 19, 2009
Registry last updated: May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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