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The Early Reversibility of Rocuronium After Different Doses of Neostigmine

The Early Reversibility of Rocuronium After Different Doses of Neostigmine

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001520
Enrollment
60
Registered
2002-12-10
Start date
1996-09-30
Completion date
2000-08-31
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paralysis

Keywords

Endotracheal Intubation, Neuromuscular Blockade, Neuromuscular Blocking Agents, Paralysis, Reversal Agents

Brief 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.

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.

Interventions

DRUGneostigmine

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026