A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
Information source: University of Edinburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Organophosphate Poisoning
Intervention: Rocuronium (Drug); Sugammadex (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Edinburgh Official(s) and/or principal investigator(s):
Indika Gawarammana, MD FRCPE PhD, Principal Investigator, Affiliation: South Asian Clinical Toxicology Research Collaboration
Michael Eddleston, MA PhD FRCP, Study Director, Affiliation: University of Edinburgh
Vasanti Pinto, MD FRCA FCARSCI, Study Director, Affiliation: University of Peradeniya
Vajira Weerasinghe, BDS MPhil PhD, Study Director, Affiliation: University of Peradeniya
Overall contact:
Indika Gawarammana, MD FRCPE PhD, Phone: 0094812384556, Email: indikagaw@gmail.com
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in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of intubated days
Detailed description:
Primary outcome: Number of days intubated
Eligibility
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Indika Gawarammana, MD FRCPE PhD, Phone: 0094812384556, Email: indikagaw@gmail.com
Peradeniya Teaching Hospital, Peradeniya, Central Province, Sri Lanka; Recruiting
Indika Gawarammana, MD FRCPE PhD, Phone: 0094812384556, Email: indikagaw@gmail.com
Additional Information
Starting date: May 2014
Last updated: June 4, 2015
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