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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01967433
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
* Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months
Exclusion Criteria:
* Inability to execute informed consent
* Allergy to Diphenhydramine, fentanyl or midazolam
* Known or suspected pregnancy
* Endoscopic procedure without sedation
* Patient scheduled to have other endoscopic procedures on the same day
* Prior alimentary tract surgery
* Severe cardiopulmonary disease (ASA IV)
* Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01967433
Study Brief:
Protocol Section:
NCT01967433