Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Nitrous Oxide Clinical Trial

Official title:

Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305158
• Other study ID #: 239435
• Status: Completed
• Phase: Early Phase 1
• Start date: March 28, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: April 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nitrous Oxide

Intervention

Drug:
• Nitrous Oxide
Patient receiving nitrous oxide are evaluated for success of the procedure

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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