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

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ClinicalTrials.gov Identifier: NCT02147054
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
University of Peradeniya
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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Brief Summary:

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.


Condition or disease Intervention/treatment Phase
Organophosphate Poisoning Drug: Rocuronium Drug: Sugammadex Phase 2 Phase 3

Detailed Description:
Primary outcome: Number of days intubated
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: Rocuronium
Other Name: Esmeron

Drug: 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 Name: Bridion
Active Comparator: 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
 Drug: Rocuronium
Other Name: Esmeron

Drug: 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 Name: Bridion
No Intervention: No Rocuronium
No Rocuronium will be given


Outcome Measures
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Primary Outcome Measures :
  1. Number of intubated days [ Time Frame: Upto 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147054


Locations
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Sri Lanka
Peradeniya Teaching Hospital
Peradeniya, Central Province, Sri Lanka
Sponsors and Collaborators
University of Edinburgh
University of Peradeniya
Investigators
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Principal Investigator: Indika Gawarammana, MD FRCPE PhD South Asian Clinical Toxicology Research Collaboration
Study Director: Michael Eddleston, MA PhD FRCP University of Edinburgh
Study Director: Vasanti Pinto, MD FRCA FCARSCI University of Peradeniya
Study Director: Vajira Weerasinghe, BDS MPhil PhD University of Peradeniya
More Information
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02147054    
Other Study ID Numbers: Rocuronium Pilot May 14
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Edinburgh:
Organophosphate poisoning
Intermediate syndrome
Rocuronium
Additional relevant MeSH terms:
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Poisoning
Organophosphate Poisoning
Chemically-Induced Disorders
Rocuronium
Neuromuscular Nondepolarizing Agents
 Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs