The Early Reversibility of Rocuronium After Different Doses of Neostigmine
Information source: National Institutes of Health Clinical Center (CC)
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Paralysis
Intervention: neostigmine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institutes of Health Clinical Center (CC)
Summary
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.
Clinical Details
Official title: The Early Reversibility of Rocuronium After Different Doses of Neostigmine
Study design: Primary Purpose: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Warren G. Magnuson Clinical Center (CC), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Martyn JA, White DA, Gronert GA, Jaffe RS, Ward JM. Up-and-down regulation of skeletal muscle acetylcholine receptors. Effects on neuromuscular blockers. Anesthesiology. 1992 May;76(5):822-43. Review. Koide M, Waud BE. Serum potassium concentrations after succinylcholine in patients with renal failure. Anesthesiology. 1972 Feb;36(2):142-5. Mayer M, Doenicke A, Hofmann A, Peter K. Onset and recovery of rocuronium (Org 9426) and vecuronium under enflurane anaesthesia. Br J Anaesth. 1992 Nov;69(5):511-2.
Starting date: September 1996
Last updated: March 3, 2008
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