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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04305158
Eligibility Criteria:
Inclusion Criteria:
Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit
Exclusion Criteria:
* High ASA risk (IV/ \>)
* History of chronic pain
* Allergy to N2O or opioid or BDZ
* No consent
* Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.
* Pneumothorax, air embolism
* Decompression sickness or within 48 hours of an underwater dive
* Severe emphysema with bullae
* Gross abdominal distension with suspicion for bowel obstruction
* Intoxication
* Maxillofacial injuries (where patient unable to administer the drug using a mouthpiece/mask, or there is the risk of causing further damage to facial wounds and there may also be a significant risk of blood inhalation)
* Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous
* Patients on Methotrexate
* Where patients need assistance to hold the mask or mouthpiece.
* Retinal surgery within the last three months
* Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04305158
Study Brief:
Protocol Section:
NCT04305158