A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
NCT ID: NCT02147054
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2014-05-31
2016-07-31
Brief Summary
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The investigators believe that blocking these receptors using a neuromuscular blocking agent such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome and reduce number of intubated days and mortality.
In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor antagonist, will be used to bind to the receptor at the neuromuscular junction and to block the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rocuronium with >95% inhibition
IV Rocuronium to be given:
* Bolus dose of Rocuronium 0.3 mg/kg to achieve \>95% inhibition as indicated by Train of Four monitoring
* Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition
* To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days
Rocuronium
Sugammadex
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Rocuronium with 50% inhibition
IV Rocuronium to be given:
* Bolus dose of Rocuronium 0.3 mg/kg to achieve 50% inhibition as indicated by Train of Four monitoring
* Continuous infusion of 1.5 mg/kg/hr to maintain level of inhibition
* To continue until two rises in butyrylcholinesterase seen or for a maximum of 5 days
Rocuronium
Sugammadex
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
No Rocuronium
No Rocuronium will be given
No interventions assigned to this group
Interventions
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Rocuronium
Sugammadex
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age over 16
* Clinical diagnosis of OP insecticide poisoning
* Admission to Intensive Care Unit for Ventilation
* Informed consent from family
* Train of four measurement \> 50%
Exclusion Criteria
* Pregnant
* Consent not obtained from patient or patient's family
17 Years
100 Years
ALL
No
Sponsors
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University of Peradeniya
OTHER
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Indika Gawarammana, MD FRCPE PhD
Role: PRINCIPAL_INVESTIGATOR
South Asian Clinical Toxicology Research Collaboration
Michael Eddleston, MA PhD FRCP
Role: STUDY_DIRECTOR
University of Edinburgh
Vasanti Pinto, MD FRCA FCARSCI
Role: STUDY_DIRECTOR
University of Peradeniya
Vajira Weerasinghe, BDS MPhil PhD
Role: STUDY_DIRECTOR
University of Peradeniya
Locations
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Peradeniya Teaching Hospital
Peradeniya, Central Province, Sri Lanka
Countries
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Other Identifiers
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Rocuronium Pilot May 14
Identifier Type: -
Identifier Source: org_study_id