Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

  • STATUS
    Recruiting
  • End date
    Nov 13, 2022
  • participants needed
    20
  • sponsor
    University of Arkansas
Updated on 13 June 2022
Accepts healthy volunteers

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

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

Details
Condition Nitrous Oxide
Treatment Nitrous Oxide
Clinical Study IdentifierNCT04305158
SponsorUniversity of Arkansas
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note