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The Early Reversibility of Rocuronium After Different Doses of Neostigmine

This study has been completed.

Sponsored by: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001520
  Purpose

Neuromuscular blocking agents are commonly used to facilitate endotracheal intubation. Succinylcholine, an ultra short-acting, depolarizing neuromuscular blocking agent, is the most commonly used agent for paralysis in this setting because of its rapid onset and short duration of paralysis. In patients with contraindications to succinylcholine or in whom a difficult airway is anticipated, a neuromuscular blocking agent with a pharmacodynamic profile similar to succinylcholine would be an attractive alternative. Rocuronium, a new intermediate-acting nondepolarizing neuromuscular blocking agent produces paralysis within 60 seconds, similar to succinylcholine, but has a duration of paralysis of approximately 20 to 30 minutes. If rocuronium-induced paralysis could be chemically reversed within 10 to 15 minutes after the administration of an intubating dose, it may be an appropriate alternative in patients with contraindications to succinylcholine or in patients whom a difficult airway is anticipated. Neostigmine is an anticholinesterase agent which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase. Inhibition of the breakdown of acetylcholine allows the neurotransmitter to be present in the neuromuscular junction for a longer period of time, so that each molecule can bind repeatedly with the acetylcholine receptor. The purpose of this study is to determine the dose of neostigmine necessary for the early reversal of rocuronium-induced paralysis.


Condition Intervention Phase
Paralysis
Drug: neostigmine
Phase IV

MedlinePlus related topics:   Paralysis   

Drug Information available for:   Neostigmine    Neostigmine bromide    Neostigmine Methylsulfate    Rocuronium    ORG 9426   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   The Early Reversibility of Rocuronium After Different Doses of Neostigmine

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   60
Study Start Date:   September 1996
Estimated Study Completion Date:   August 2000

Detailed Description:

Neuromuscular blocking agents are commonly used to facilitate endotracheal intubation. Succinylcholine, an ultra short-acting, depolarizing neuromuscular blocking agent, is the most commonly used agent for paralysis in this setting because of its rapid onset and short duration of paralysis. In patients with contraindications to succinylcholine or in whom a difficult airway is anticipated, a neuromuscular blocking agent with a pharmacodynamic profile similar to succinylcholine would be an attractive alternative. Rocuronium, a new intermediate-acting nondepolarizing neuromuscular blocking agent produces paralysis within 60 seconds, similar to succinylcholine, but has a duration of paralysis of approximately 20 to 30 minutes. If rocuronium-induced paralysis could be chemically reversed within 10 to 15 minutes after the administration of an intubating dose, it may be an appropriate alternative in patients with contraindications to succinylcholine or in patients whom a difficult airway is anticipated. Neostigmine is an anticholinesterase agent which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase. Inhibition of the breakdown of acetylcholine allows the neurotransmitter to be present in the neuromuscular junction for a longer period of time, so that each molecule can bind repeatedly with the acetylcholine receptor. The purpose of this study is to determine the dose of neostigmine necessary for the early reversal of rocuronium-induced paralysis.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

American Society of Anethesiology Class I-III adult patients undergoing elective surgery requiring neuromuscular blockage for endotracheal intubation.

No pre-existing renal or hepatic disease, Myasthenia-Gravis, Eaton-Lambert Disease, pregnancy, concurrent anticonvulsant therapy, history of hypersensitivity to rocuronium, neostigmine, or glycopyrrolate.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001520

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


Publications:

Study ID Numbers:   960122, 96-CC-0122
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001520
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Endotracheal Intubation  
Neuromuscular Blockade  
Neuromuscular Blocking Agents  
Paralysis  
Reversal Agents  

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Neostigmine
Rocuronium
Neurologic Manifestations

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

ClinicalTrials.gov processed this record on November 30, 2008




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