Clinical trial NCT00847938: Comparision of Different Dose of Neostigmine at Advanced Decurarization
Official title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: neostigmine
neuromuscular blocking agent
train of four
anesthesia
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mesure of the Train-of-four (TOF)
timeFrame: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: CHD Vendée
Study officials:
affiliation: CHD Vendee
name: Florent Capron, doctor
role: PRINCIPAL_INVESTIGATOR
References: