Colon Cancer Clinical Trial

Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

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

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Full Description

Patients who are considered low risk for anesthesia administration (ASA class

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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)

Study is for people with:

Colon Cancer

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT04305158

Recruitment Status:

Recruiting

Sponsor:

University of Arkansas

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There is 1 Location for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States More Info
Benjamin Tharian, MD, MRCP, FACP, FRACP
Contact
501-686-7847
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT04305158

Recruitment Status:

Recruiting

Sponsor:


University of Arkansas

How clear is this clinincal trial information?

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