- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001520
The Early Reversibility of Rocuronium After Different Doses of Neostigmine
March 3, 2008 updated by: National Institutes of Health Clinical Center (CC)
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 Overview
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 Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1996
Study Completion
August 1, 2000
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (Estimate)
December 10, 2002
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
September 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Paralysis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Cholinesterase Inhibitors
- Parasympathomimetics
- Neostigmine
Other Study ID Numbers
- 960122
- 96-CC-0122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Paralysis
-
Neurotrigger LtdRecruitingParalysis | Paralysis; Eye | Paralysis; BellIsrael
-
Assistance Publique - Hôpitaux de ParisCompletedUnilateral Diaphragmatic ParalysisFrance
-
University Hospital, RouenUniversity Hospital, CaenCompleted
-
Lawson Health Research InstituteSuspended
-
University of MinnesotaCompleted
-
Seoul National University HospitalCompleted
-
Ben-Gurion University of the NegevCompleted
-
Brigham and Women's HospitalCompletedPhrenic Nerve ParalysisUnited States
-
Shenzhen People's HospitalUnknownPhrenic Nerve ParalysisChina
-
Ajou University School of MedicineWithdrawnPhrenic Nerve ParalysisKorea, Republic of
Clinical Trials on neostigmine
-
Pontificia Universidade Catolica de Sao PauloNot yet recruitingNeuromuscular Blockade | Neuromuscular Blockade, ResidualBrazil
-
NorthShore University HealthSystemCompleted
-
Korea University Ansan HospitalNot yet recruitingCOVID-19 | General Anesthesia
-
Onze Lieve Vrouw HospitalCompletedRespiratory Muscles | ElectromyographyBelgium
-
Merck Sharp & Dohme LLCCompleted
-
Pontificia Universidade Catolica de Sao PauloNot yet recruitingNeuromuscular Blockade | Neuromuscular Block, Residual | Neuromuscular Block Prolonged
-
Konkuk University Medical CenterNot yet recruitingStrabismus | Emergence Delirium | Pediatric ALL
-
Alexandria UniversityKasr El Aini Hospital; Fayoum UniversityCompletedPost-Dural Puncture HeadacheEgypt
-
James J. Peters Veterans Affairs Medical CenterUnknownNeurogenic Bowel | Spinal Cord InjuryUnited States
-
Merck Sharp & Dohme LLCCompleted