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Nitrous Oxide Sedation for Endoscopy

Phase 4
Recruiting
Research Sponsored by Stanford University
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
Must not have
Age <18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-36 hours
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

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.
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.
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 below
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I am over 18 and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-36 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-36 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fatigue
Intravenous sedative drug
Mental Fogginess post-procedure/sedation
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial 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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,064 Total Patients Enrolled

Media Library

50% inhaled nitrous oxide Clinical Trial Eligibility Overview. Trial Name: NCT05396144 — Phase 4
Endoscopy Research Study Groups: 5% inhaled nitrous oxide, 50% inhaled nitrous oxide
Endoscopy Clinical Trial 2023: 50% inhaled nitrous oxide Highlights & Side Effects. Trial Name: NCT05396144 — Phase 4
50% inhaled nitrous oxide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396144 — Phase 4
~0 spots leftby Jan 2025
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