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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT00847938
First received: February 18, 2009
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization .

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

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: Florent Caperon (medical doctor), CHD Vendée
ClinicalTrials.gov Identifier: NCT00847938     History of Changes
Other Study ID Numbers: CHD066-08
Study First Received: February 18, 2009
Last Updated: November 30, 2009
Health Authority: France: Agence Fançaise de Sécurité SAnitaire des Produits de Santé

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

Additional relevant MeSH terms:
Neostigmine
Neuromuscular Blocking Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on September 26, 2012