NCT04305158

Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 anxiety and discomfort and to improve the outcome of the examination. Use of N2O could potentially provide an alternate safe and cheap option for patients who do not prefer IV sedation for colonoscopy

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 method of providing analgesia with "on-demand" inhalation of nitrous oxide (hereafter referred to as N2O) combined with oxygen has been postulated. Nitrous Oxide has been used for analgesia in various procedures including childbirth, general anesthesia, pediatric dentistry, bone marrow aspiration, fracture reductions, and minor surgical procedures (surgical dressings, pulmonary endoscopy, an abscess . It could potentially reduce overall costs for the procedure, in addition to providing a quicker recovery, turn over

Conditions

• Nitrous Oxide

Interventions

Type	Name	Description
DRUG	Nitrous Oxide	Patient receiving nitrous oxide are evaluated for success of the procedure

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-08-10
• Completion: 2023-08-10
• First posted: 2020-03-12
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study