Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Study Overview
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Brief Summary
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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
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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

Official Title
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Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Conditions
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Nitrous Oxide

Intervention / Treatment
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* Drug: Nitrous Oxide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrous Oxide<br>Patient receiving Nitrous Oxide are evaluated for success of the procedure | Drug: Nitrous Oxide<br>* Patient receiving nitrous oxide are evaluated for success of the procedure<br>|
| Active Comparator: IV Sedation group<br>In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion | Drug: Nitrous Oxide<br>* Patient receiving nitrous oxide are evaluated for success of the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation rates and time of the procedure - total time and recovery | Time required to complete the procedure and reach end of the colon | 1 to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate sedation, Nitrous oxide, Screen colonoscopy