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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 30 minutes
Awards & highlights
Study Summary
This trial found that N2O could be a safe and cheap option for sedation during colonoscopy for patients who do not prefer IV sedation.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 to 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cecal intubation rates and time of the procedure - total time and recovery
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
486 Previous Clinical Trials
150,153 Total Patients Enrolled
Benjamin Tharian, MD, MRCP, FACP, FRACPPrincipal InvestigatorUniversity of Arkansas
Stephan Dehmel, MDPrincipal InvestigatorUniversity of Arkansas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe lung damage with large air pockets.I need general anesthesia because standard sedation doesn't work for me.I have a colonoscopy appointment at the Endoscopy unit.I have not had decompression sickness or dived underwater in the last 48 hours.I am currently taking Methotrexate.I've had a recent head injury or surgery that affected my consciousness.I am over 18 years old.I have never had a collapsed lung or air bubbles in my blood.You are under the influence of drugs or alcohol.I cannot use a mouthpiece or mask for medication due to facial injuries.I have a long-term history of pain.I have lung disease and cannot safely breathe air with more than 28% oxygen.I have not had retinal surgery in the last three months.I have a noticeably swollen belly and may have a blockage in my intestines.You are allergic to nitrous oxide, opioids, or benzodiazepines.
Research Study Groups:
This trial has the following groups:- Group 1: Nitrous Oxide
- Group 2: IV Sedation group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this clinical trial?
"Affirmative, the information on clinicaltrials.gov demonstrates that this trial is still seeking participants. This research project was originally posted on March 28th 2022 and has been updated most recently as of November 14th 2022. In total, 20 patients are needed at 1 medical facility for the study to commence."
Answered by AI
Is there still availability to partake in this investigation for prospective volunteers?
"Yes, indeed. According to the information available on clinicaltrials.gov, this medical research is presently in need of participants and has been actively recruiting since March 28th 2022. Furthermore, it was last modified on November 14th 2022, with a requirement for 20 individuals from one centre."
Answered by AI
Could you provide a synopsis of past experiments involving Nitrous Oxide?
"Currently, 12 studies of Nitrous Oxide are ongoing with 1 live Phase 3 study. These trials are being conducted at 12 sites across Saint Louis, Missouri."
Answered by AI
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