ParalysisPhase 4NCT00001520
The Early Reversibility of Rocuronium After Different Doses of Neostigmine
A Phase 4 study testing neostigmine in people with Paralysis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paralysis
- What is being tested?
- neostigmine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Aug 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Paralysis
- Being tested
- neostigmine
- Keywords
- Endotracheal Intubation, Neuromuscular Blockade, Neuromuscular Blocking Agents, Paralysis, Reversal Agents
- Medical subject headings
- Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startSep 1996
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001520
- Sponsor's protocol ID
- 960122
- Other IDs
- 96-CC-0122
- Status last verified
- Sep 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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. doi: 10.1097/00000542-199205000-00022.
PubMed 1575351Koide 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.
PubMed 5059104Mayer 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.
PubMed 1361356
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Reversibility of Rocuronium After Different Doses of Neostigmine
- ClinicalTrials.gov ID
- NCT00001520
- Acronym / sponsor ID
- 960122
- Conditions
- Paralysis
- Keywords
- Endotracheal Intubation, Neuromuscular Blockade, Neuromuscular Blocking Agents, Paralysis, Reversal Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Aug 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neostigmine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1575351Martyn 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.
- Background: PubMed 5059104Koide 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.
- Background: PubMed 1361356Mayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing neostigmine in people with Paralysis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001520, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.