A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning

Study Overview
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Brief Summary
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Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. Much of the mortality in these ventilated patients is secondary to intermediate syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest or prolonged ventilation and its associated complications. 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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.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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Primary outcome: Number of days intubated

Official Title
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Pilot Study - Assessing the Impact of Using a Neuromuscular Blocking Agent to Reduce Neuromuscular Junction Damage and Intermediate Syndrome in Organophosphorus (OP) Insecticide Poisoned Patients Requiring Ventilation

Conditions
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Organophosphate Poisoning

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female 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: Age 16 or under Pregnant Consent not obtained from patient or patient's family

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium with >95% inhibition<br>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 | Drug: Rocuronium<br> <br> * Other names: Esmeron;Drug: Sugammadex<br>* Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.<br>* Other names: Bridion;|
| Active Comparator: Rocuronium with 50% inhibition<br>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 | Drug: Rocuronium<br> <br> * Other names: Esmeron;Drug: Sugammadex<br>* Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.<br>* Other names: Bridion;|
| No Intervention: No Rocuronium<br>No Rocuronium will be given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intubated days |  | Upto 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organophosphate poisoning, Intermediate syndrome, Rocuronium