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

Organophosphate Poisoning Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147054
• Other study ID #: Rocuronium Pilot May 14
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 21, 2014
• Last updated: November 16, 2016
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: University of Peradeniya Ethics Review Committee
• Study type: Interventional

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Description:

Primary outcome: Number of days intubated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Organophosphate Poisoning
• Poisoning

Intervention

Drug:
• Rocuronium

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

Locations

Country	Name	City	State
Sri Lanka	Peradeniya Teaching Hospital	Peradeniya	Central Province

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	University of Peradeniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intubated days		Upto 5 days	No