Status:
COMPLETED
Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA
Lead Sponsor:
University of Arkansas
Conditions:
Nitrous Oxide
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Colon cancer is the second most common cancer in men and the third most common cancer in women worldwide. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxi...
Detailed Description
Patients who are considered low risk for anesthesia administration (ASA class \<IV) receive moderate sedation with a combination of intravenous benzodiazepine and opioid medication. an alternative met...
Eligibility Criteria
Inclusion
- Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit
Exclusion
- 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)
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04305158
Start Date
March 28 2022
End Date
August 10 2023
Last Update
April 11 2024
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205