Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

NCT04305158 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 239435
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Nitrous Oxide

Keywords

Moderate sedation; Nitrous oxide; Screen colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nitrous Oxide

EXPERIMENTAL

Patient receiving Nitrous Oxide are evaluated for success of the procedure

Drug: Nitrous Oxide

IV Sedation group

ACTIVE COMPARATOR

In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

Patient receiving nitrous oxide are evaluated for success of the procedure

IV Sedation group; Nitrous Oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Stephan Dehmel, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: March 28, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (1)