Clinical trial NCT04305158: Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA
Official title: Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nitrous Oxide
Keywords: Moderate sedation
Nitrous oxide
Screen colonoscopy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Cecal intubation rates and time of the procedure - total time and recovery
timeFrame: 1 to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Stephan Dehmel, MD
role: PRINCIPAL_INVESTIGATOR
References: