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Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04305158
Enrollment
200
Registered
2020-03-12
Start date
2022-03-28
Completion date
2023-08-10
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nitrous Oxide

Keywords

Moderate sedation, Nitrous oxide, Screen colonoscopy

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 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

Interventions

DRUGNitrous Oxide

Patient receiving nitrous oxide are evaluated for success of the procedure

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Cecal intubation rates and time of the procedure - total time and recovery1 to 30 minutesTime required to complete the procedure and reach end of the colon

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026