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

November 16, 2016 updated by: University of Edinburgh

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

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary outcome: Number of days intubated

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • Central Province
      • Peradeniya, Central Province, Sri Lanka
        • Peradeniya Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 96 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rocuronium with >95% inhibition

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
Drug: Rocuronium
Other Names:
  • Esmeron
Drug: Sugammadex
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Other Names:
  • Bridion
Active Comparator: Rocuronium with 50% inhibition

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
Drug: Rocuronium
Other Names:
  • Esmeron
Drug: Sugammadex
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Other Names:
  • Bridion
No Intervention: No Rocuronium
No Rocuronium will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of intubated days
Time Frame: Upto 5 days
Upto 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

University of Peradeniya

Investigators

  • Principal Investigator: Indika Gawarammana, MD FRCPE PhD, South Asian Clinical Toxicology Research Collaboration
  • Study Director: Michael Eddleston, MA PhD FRCP, University of Edinburgh
  • Study Director: Vasanti Pinto, MD FRCA FCARSCI, University of Peradeniya
  • Study Director: Vajira Weerasinghe, BDS MPhil PhD, University of Peradeniya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rocuronium Pilot May 14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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