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

Phase 2

Completed

• Conditions: Organophosphate Poisoning
• Interventions: Drug: Rocuronium; Drug: Sugammadex

• Registration Number: NCT02147054
• Lead Sponsor: University of Edinburgh

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-26
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium with >95% inhibition	Rocuronium	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
Rocuronium with >95% inhibition	Sugammadex	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
Rocuronium with 50% inhibition	Rocuronium	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
Rocuronium with 50% inhibition	Sugammadex	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

Primary Outcome Measures

Name	Time	Method
Number of intubated days	Upto 5 days

Trial Locations

Locations (1)

Peradeniya Teaching Hospital; 🇱🇰 Peradeniya, Central Province, Sri Lanka