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OpenTrials
Completed

NCT Number: NCT04305158

Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nitrous Oxide

Drug

Patient receiving nitrous oxide are evaluated for success of the procedure

Primary outcomes

  1. Cecal intubation rates and time of the procedure - total time and recovery

    Time frame: 1 to 30 minutes

    Time required to complete the procedure and reach end of the colon

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2020
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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