search
Back to results

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

Primary Purpose

Organophosphate Poisoning

Status
Completed
Phase
Phase 2
Locations
Sri Lanka
Study Type
Interventional
Intervention
Rocuronium
Sugammadex
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organophosphate Poisoning focused on measuring Organophosphate poisoning, Intermediate syndrome, Rocuronium

Eligibility Criteria

17 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peradeniya Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Rocuronium with >95% inhibition

Rocuronium with 50% inhibition

No Rocuronium

Arm 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

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

No Rocuronium will be given

Outcomes

Primary Outcome Measures

Number of intubated days

Secondary Outcome Measures

Full Information

First Posted
May 21, 2014
Last Updated
November 16, 2016
Sponsor
University of Edinburgh
Collaborators
University of Peradeniya
search

1. Study Identification

Unique Protocol Identification Number
NCT02147054
Brief Title
A Pilot Study Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
University of Peradeniya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organophosphate Poisoning
Keywords
Organophosphate poisoning, Intermediate syndrome, Rocuronium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rocuronium with >95% inhibition
Arm Type
Active Comparator
Arm 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
Arm Title
Rocuronium with 50% inhibition
Arm Type
Active Comparator
Arm 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
Arm Title
No Rocuronium
Arm Type
No Intervention
Arm Description
No Rocuronium will be given
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Esmeron
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
Primary Outcome Measure Information:
Title
Number of intubated days
Time Frame
Upto 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indika Gawarammana, MD FRCPE PhD
Organizational Affiliation
South Asian Clinical Toxicology Research Collaboration
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Eddleston, MA PhD FRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vasanti Pinto, MD FRCA FCARSCI
Organizational Affiliation
University of Peradeniya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vajira Weerasinghe, BDS MPhil PhD
Organizational Affiliation
University of Peradeniya
Official's Role
Study Director
Facility Information:
Facility Name
Peradeniya Teaching Hospital
City
Peradeniya
State/Province
Central Province
Country
Sri Lanka

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs