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Laughing Gas Sedation for Colonoscopies

Phase < 1
Waitlist Available
Led By Benjamin Tharian, MD, MRCP, FACP, FRACP
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)
Severe emphysema with bullae
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing nitrous oxide mixed with oxygen to help low-risk patients relax and feel less pain during a colonoscopy. This method could be a safer and cheaper alternative to traditional methods, providing quicker recovery and lower costs. Nitrous oxide is efficient and safer than other pain relief methods, and it has been shown to improve patient experience with quicker recovery times and minimal after effects.

Who is the study for?
This trial is for men and women over 18 who are scheduled for a colonoscopy. It's not suitable for those with certain lung diseases, recent eye or brain surgery, severe emphysema, bowel obstruction concerns, chronic pain issues, diving activities within 48 hours, allergies to N2O or specific sedatives, pneumothorax (collapsed lung), intoxication or facial injuries.
What is being tested?
The study is testing the use of nitrous oxide (laughing gas) as an alternative to traditional IV sedation during colonoscopies. The goal is to see if it can reduce anxiety and discomfort more safely and cheaply than current methods.
What are the potential side effects?
Potential side effects of using nitrous oxide may include nausea, vomiting, dizziness, headaches or feelings of euphoria. Long-term exposure in medical settings is rare but could lead to vitamin B12 deficiency and nerve damage.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need general anesthesia because standard sedation doesn't work for me.
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I have severe lung damage with large air pockets.
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I have not had decompression sickness or dived underwater in the last 48 hours.
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I am currently taking Methotrexate.
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I've had a recent head injury or surgery that affected my consciousness.
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I have never had a collapsed lung or air bubbles in my blood.
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I cannot use a mouthpiece or mask for medication due to facial injuries.
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I have lung disease and cannot safely breathe air with more than 28% oxygen.
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I have not had retinal surgery in the last three months.
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I have a noticeably swollen belly and may have a blockage in my intestines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cecal intubation rates and time of the procedure - total time and recovery

Side effects data

From 2018 Phase 4 trial • 63 Patients • NCT03085563
7%
hypoxia
2%
paradoxical reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intranasal Midazolam
Nitrous Oxide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nitrous OxideExperimental Treatment1 Intervention
Patient receiving Nitrous Oxide are evaluated for success of the procedure
Group II: IV Sedation groupActive Control1 Intervention
In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrous Oxide
2016
Completed Phase 4
~8380

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,130 Total Patients Enrolled
Benjamin Tharian, MD, MRCP, FACP, FRACPPrincipal InvestigatorUniversity of Arkansas
Stephan Dehmel, MDPrincipal InvestigatorUniversity of Arkansas

Media Library

Nitrous Oxide Clinical Trial Eligibility Overview. Trial Name: NCT04305158 — Phase < 1
Laughing Gas Research Study Groups: Nitrous Oxide, IV Sedation group
Laughing Gas Clinical Trial 2023: Nitrous Oxide Highlights & Side Effects. Trial Name: NCT04305158 — Phase < 1
Nitrous Oxide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305158 — Phase < 1
~56 spots leftby Nov 2025
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