Skip to content

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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02147054
Enrollment
45
Registered
2014-05-26
Start date
2014-05-31
Completion date
2016-07-31
Last updated
2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organophosphate Poisoning

Keywords

Organophosphate poisoning, Intermediate syndrome, Rocuronium

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.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

Interventions

DRUGRocuronium
DRUGSugammadex

Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.

Sponsors

University of Peradeniya
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of intubated daysUpto 5 days

Countries

Sri Lanka

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026