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

University of Edinburgh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Organophosphate Poisoning

Treatments: Drug: Sugammadex; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02147054

Rocuronium Pilot May 14

Details and patient eligibility

About

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Full description

Primary outcome: Number of days intubated

Enrollment: 45 patients

Sex: All

Ages: 17 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Rocuronium with >95% inhibition

Active Comparator group

Description:

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

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Rocuronium with 50% inhibition

Active Comparator group

Description:

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

Treatment:

Drug: Rocuronium

Drug: Sugammadex

No Rocuronium

No Intervention group

Description:

No Rocuronium will be given