Clinical trial NCT02147054: A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Organophosphate Poisoning
Keywords: Organophosphate poisoning
Intermediate syndrome
Rocuronium
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Peradeniya
First posted: 2014-05-26
Enrollment: 45
Sex: ALL
Minimum age (years): 17
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Detailed description: Primary outcome: Number of days intubated

Eligibility 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

Primary outcomes:
measure: Number of intubated days
timeFrame: Upto 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Peradeniya
country: Sri Lanka
facility: Peradeniya Teaching Hospital
state: Central Province
Study officials:
affiliation: South Asian Clinical Toxicology Research Collaboration
name: Indika Gawarammana, MD FRCPE PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Michael Eddleston, MA PhD FRCP
role: STUDY_DIRECTOR
affiliation: University of Peradeniya
name: Vasanti Pinto, MD FRCA FCARSCI
role: STUDY_DIRECTOR
affiliation: University of Peradeniya
name: Vajira Weerasinghe, BDS MPhil PhD
role: STUDY_DIRECTOR
References: