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

Study Overview

• Status: Completed
• Conditions: Nitrous Oxide
• Intervention / Treatment: Drug: Nitrous Oxide

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Stephan Dehmel, MD; Phone Number: 269-569-3719; Email: sdehmel@uams.edu
• Study Contact Backup: Name: Chandra Dasari; Phone Number: 330-224-6739; Email: csdasari@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrous Oxide; Patient receiving Nitrous Oxide are evaluated for success of the procedure	Drug: Nitrous Oxide; Patient receiving nitrous oxide are evaluated for success of the procedure
Active Comparator: IV Sedation group; In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion	Drug: Nitrous Oxide; Patient receiving nitrous oxide are evaluated for success of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Stephan Dehmel, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Moderate sedation; Nitrous oxide; Screen colonoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 239435

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No