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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

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SLCTR Registration Number

SLCTR/2014/018

Date of Registration

17 Sep 2014

The date of last modification

Apr 30, 2019

Trial Status


Application Summary

Scientific Title of Trial

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

Public Title of Trial

Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning

Disease or Health Condition(s) Studied

Organophosphate poisoning

Scientific Acronym

None

Public Acronym

None

Brief title

Using Rocuronium to Prevent Intermediate Syndrome After Organophosphorus Insecticide Poisoning

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

None


Trial Details

What is the research question being addressed?

Will the early administration of a neuromuscular blocking agent (NMBA) to an organophosphorus (OP) insecticide poisoned patient requiring ventilation reduce acetylcholine-induced damage to the neuromuscular junction and prevent the occurrence of the intermediate syndrome?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2-3

Intervention(s) planned

Patients meeting inclusion/exclusion criteria will be randomized into three arms.

The first arm will receive standard therapy alone (no rocuronium)

The second arm will receive rocuronium bolus and infusion sufficient to reduce neuromuscular transmission by 50% as measured using standard anaesthetic Train of Four neurophysiological measures

The second arm will receive rocuronium bolus and infusion sufficient to reduce neuromuscular transmission by more than 95% as measured using standard anaesthetic Train of Four neurophysiological measures

Inclusion criteria

  1. Male or female
  2. Age over 16 years
  3. Clinical diagnosis of OP insecticide poisoning
  4. Admission to Intensive Care Unit for ventilation
  5. Informed consent from family
  6. An initial Train-of-Four measurement (Neuromuscular junction function) of > 50% using standard anaesthetic neurophysiology equipment

Exclusion criteria

  1. Failure to obtain informed consent from patient’s family
  2. Age 16 years or younger
  3. Patients who are pregnant
  4. Patients will be removed from the study at their own or their family’s request

Primary outcome(s)

1.

Number of days ventilated

 [

On extubation

]

Secondary outcome(s)

1.

Train of four measurement on repetitive nerve stimulation.

 [

Every Ventillated day for a maximum of 5 days

]

Target number/sample size

45

Countries of recruitment

Sri Lanka

Anticipated start date

2014-05-20

Anticipated end date

2014-12-31

Date of first enrollment

2014-07-20

Date of study completion

Recruitment status

Recruiting

Funding source

South Asian Clinical Toxicology Research Collaboration

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-02-10

Approval number

N/A

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Galaha Road, Kandy, Sri Lanka
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Professor Indika Gawarammana
Principle investigator, Director South Asian Clinical Toxicology Research Collaboration
Department of Medicine Faculty of Medicine University of Peradeniya Peradeniya Sri Lanka
0094-81-2384556

081-2224125
indika@sactrc.org
http://www.sactrc.org

Contact Person for Public Queries

Professor Indika Gawarammana
Principle investigator, Director South Asian Clinical Toxicology Research Collaboration
Department of Medicine Faculty of Medicine University of Peradeniya Peradeniya Sri Lanka
0094-81-2384556

081-2224125
indika@sactrc.org
http://www.sactrc.org

Primary study sponsor/organization

South Asian Clinical Toxicology Research Collaboration

SACTRC Faculty of Medicine University of Peradeniya Peradeniya Sri Lanka
0094-81-2384556
0094-81-4479822
enquiry@sactrc.org
http://www.sactrc.org

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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