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	Phase
Paralysis	Phase IV

Further Study Details: 

Expected Total Enrollment:  60

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.

Genders Eligible for Study:  Both

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.

Maryland
      Warren G. Magnuson Clinical Center (CC), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

Study ID Numbers:  960122; 96-CC-0122
Record last reviewed:  September 17, 1999
Last Updated:  December 11, 2002
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001520
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08