The Early Reversibility of Rocuronium After Different Doses of Neostigmine
Primary Purpose
Paralysis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
neostigmine
Sponsored by
About this trial
This is an interventional treatment trial for Paralysis focused on measuring Endotracheal Intubation, Neuromuscular Blockade, Neuromuscular Blocking Agents, Paralysis, Reversal Agents
Eligibility 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.
Sites / Locations
- Warren G. Magnuson Clinical Center (CC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001520
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT00001520
Brief Title
The Early Reversibility of Rocuronium After Different Doses of Neostigmine
Official Title
The Early Reversibility of Rocuronium After Different Doses of Neostigmine
Study Type
Interventional
2. Study Status
Record Verification Date
September 1999
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis
Keywords
Endotracheal Intubation, Neuromuscular Blockade, Neuromuscular Blocking Agents, Paralysis, Reversal Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
neostigmine
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1575351
Citation
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. doi: 10.1097/00000542-199205000-00022.
Results Reference
background
PubMed Identifier
5059104
Citation
Koide M, Waud BE. Serum potassium concentrations after succinylcholine in patients with renal failure. Anesthesiology. 1972 Feb;36(2):142-5. doi: 10.1097/00000542-197202000-00013. No abstract available.
Results Reference
background
PubMed Identifier
1361356
Citation
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. doi: 10.1093/bja/69.5.511.
Results Reference
background
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The Early Reversibility of Rocuronium After Different Doses of Neostigmine
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