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NCT00001520 · ClinicalTrials.gov registry record · Phase 4

The Early Reversibility of Rocuronium After Different Doses of Neostigmine

A Phase 4 study of Paralysis, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 4
Development phase
60
Enrollment target
1
Study location

NCT00001520 is a Phase 4 study of Paralysis that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 60 participants, above the 20-participant average among 13 other Paralysis trials with a reported enrollment target (200% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00001520, a Phase 4 study of Paralysis, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG neostigmine

Study Locations (1)

Maryland

  • Warren G. Magnuson Clinical Center (CC) - Bethesda

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 1996-09
Est. Completion 2000-08
Phase Phase 4

What the Registry Record Tells You About NCT00001520

The ClinicalTrials.gov registry entry for NCT00001520 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 20-participant average among 13 other Paralysis trials with a reported enrollment target (200% higher). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Paralysis appearing as the primary indexed condition, and to 1 intervention - of which neostigmine is the first listed.

NCT00001520 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001520 about?

NCT00001520 is a clinical study titled "The Early Reversibility of Rocuronium After Different Doses of Neostigmine". 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 patie...

What is the current status of trial NCT00001520?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 1996-09. Estimated completion is 2000-08.

What conditions does trial NCT00001520 study?

This clinical trial studies the following conditions: Paralysis.

What interventions are being tested in trial NCT00001520?

The interventions under investigation include: neostigmine (DRUG).

Who is sponsoring clinical trial NCT00001520?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001520 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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