Comparision of Different Dose of Neostigmine at Advanced Decurarization - Full Text View

Sponsored by:	Centre Hospitalier Departemental Vendee
Information provided by:	Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:	NCT00847938

Purpose

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.

Condition	Intervention	Phase
Anesthesia	Drug: neostigmine	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Neostigmine Methylsulfate Neostigmine Neostigmine bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Controlled, Double-Blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:

mesure of the train of four, vitals signs, electrocardiogramm, bispectral index of Electro-encephalogram measuring the depth of anesthesia [ Time Frame: inclusion, anesthesia, anesthesia +6 hours, anesthesia + 12 hours, anesthesia +24h, anesthesia +48 h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg	Drug: neostigmine 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
2: Active Comparator neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg	Drug: neostigmine 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
3: Active Comparator neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg	Drug: neostigmine 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
4: No Intervention no injection of neostigmine

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847938

Contacts

Contact: Jérome Dimet, pharmacist

+33251446467

recherche.clinique@chd-vendee.fr

Locations

France
CHD Vendée
La Roche Sur Yon, France, 85925

Sponsors and Collaborators

Centre Hospitalier Departemental Vendee

Investigators

Principal Investigator:

Florent Capron, doctor

CHD Vendee

More Information

No publications provided

Responsible Party:	CHD Vendée ( Florent Caperon (medical doctor) )
Study ID Numbers:	CHD066-08
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00847938 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Hospitalier Departemental Vendee:

neostigmine
neuromuscular blocking agent
train of four
anesthesia

Study placed in the following topic categories:

Cholinesterase Inhibitors
Neurotransmitter Agents
Neostigmine
Anesthetics

Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Cholinergic Agents

Additional relevant MeSH terms:

Parasympathomimetics
Neurotransmitter Agents
Neostigmine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuromuscular Blocking Agents
Enzyme Inhibitors

Neuromuscular Agents
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009