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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-pregnant patients age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-36 hours
Awards & highlights
Study Summary
This trial will test the hypothesis that use of nitrous oxide during GI endoscopy will decrease fatigue, mental fogginess, and nausea/vomiting, as well as determine when the patient felt fully recovered from the effects of all sedatives given for the procedure.
Who is the study for?
This trial is for non-pregnant adults over 18 who need an upper endoscopy or colonoscopy with nurse-directed sedation. Participants must be able to consent and follow study procedures. It's not for those in other studies, allergic to certain anesthetics, under 18, or vulnerable populations like the homeless or pregnant women.Check my eligibility
What is being tested?
The trial tests if Nitrous Oxide (laughing gas) can improve comfort and recovery after GI endoscopies compared to standard drugs. It aims to see if it reduces fatigue, mental fogginess, nausea/vomiting and speeds up full recovery from sedatives.See study design
What are the potential side effects?
Nitrous oxide may cause side effects such as dizziness, nausea, vomiting, headache or feeling tired. These are generally mild and short-lived due to the gas quickly leaving the body after the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-36 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-36 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue
Intravenous sedative drug
Mental Fogginess post-procedure/sedation
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: 50% inhaled nitrous oxideActive Control1 Intervention
Patients will received 50% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.
Group II: 5% inhaled nitrous oxidePlacebo Group1 Intervention
Patients will received 5% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,520 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and not pregnant.I am scheduled for an upper endoscopy or colonoscopy with nurse-led sedation.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 5% inhaled nitrous oxide
- Group 2: 50% inhaled nitrous oxide
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Does the FDA sanction a 50% concentration of inhaled nitrous oxide?
"Our team determined that 50% inhaled nitrous oxide was a safe treatment, evidenced by the Phase 4 rating. This indicates that it has been approved for medical use."
Answered by AI
Are any additional participants still being recruited for this clinical experiment?
"Clinicaltrials.gov indicates that this specific investigation is not currently recruiting participants, as the last update was made on May 24th 2022. However, 23 other studies are actively searching for individuals to enroll in their programs."
Answered by AI
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