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Comparision of Different Dose of Neostigmine at Advanced Decurarization (NEODEC)

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ClinicalTrials.gov Identifier: NCT00847938
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : December 1, 2009
Information provided by:
Centre Hospitalier Departemental Vendee

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: neostigmine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .
Study Start Date : March 2009
Primary Completion Date : October 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
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 %
Active Comparator: 2
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 %
Active Comparator: 3
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 %
No Intervention: 4
no injection of neostigmine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847938

CHD Vendée
La Roche Sur Yon, France, 85925
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Principal Investigator: Florent Capron, doctor CHD Vendee

Responsible Party: Florent Caperon (medical doctor), CHD Vendée
ClinicalTrials.gov Identifier: NCT00847938     History of Changes
Other Study ID Numbers: CHD066-08
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by Centre Hospitalier Departemental Vendee:
neuromuscular blocking agent
train of four

Additional relevant MeSH terms:
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents