Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT00389259
Eligibility Criteria:
Inclusion Criteria:
* Age: 2- 60 years
* At least two of the following three criteria:
* Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
* Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
* Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
* CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
Major criteria for CNS involvement:
* Seizures
* Extrapyramidal or Parkinson like symptoms
* Decreased level of consciousness (GCS\< 12)
Minor criteria for CNS involvement:
* GCS 14-12
* Confusion
* Hallucinations
Exclusion Criteria:
* Hypersensitivity to scopolamine
* Glaucoma, narrow-angle (angle-closure)
* Tachyarrhythmias, congestive heart failure
* Obstructive gastrointestinal disease
* Myasthenia Gravis
* Reflux esophagitis
* Ulcerative colitis
* Known obstructive uropathy
* Pregnancy
* Patient or legal guardian unable to give informed consent (see comment under ethics)
* Severe co-morbidity (multi-trauma, advanced cancer, etc)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
60 Years
Study:
NCT00389259
Study Brief:
Protocol Section:
NCT00389259