NCT02147054

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 The effects of OP pesticide on cholinesterase in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is eliminated from the body.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

May 21, 2014

Last Update Submit

November 16, 2016

Conditions

Organophosphate Poisoning

Keywords

Organophosphate poisoningIntermediate syndromeRocuronium

Outcome Measures

Primary Outcomes (1)

  • Number of intubated days

    Upto 5 days

Study Arms (3)

Rocuronium with >95% inhibition

ACTIVE COMPARATOR

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: RocuroniumDrug: Sugammadex

Rocuronium with 50% inhibition

ACTIVE COMPARATOR

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: RocuroniumDrug: Sugammadex

No Rocuronium

NO INTERVENTION

No Rocuronium will be given

Interventions

RocuroniumDRUG
Also known as: Esmeron
Rocuronium with 50% inhibitionRocuronium with >95% inhibition
SugammadexDRUG

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

Also known as: Bridion
Rocuronium with 50% inhibitionRocuronium with >95% inhibition

Eligibility Criteria

Age17 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Age 16 or under
  • Pregnant
  • Consent not obtained from patient or patient's family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peradeniya Teaching Hospital

Peradeniya, Central Province, Sri Lanka

Location

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

RocuroniumSugammadex

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Indika Gawarammana, MD FRCPE PhD

    South Asian Clinical Toxicology Research Collaboration

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 26, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

SR(1)