Nitrous Oxide Sedation for Endoscopy

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stanford University

Disqualifiers: Age <18, Pregnant, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Nitrous oxide (commonly known as 'laughing gas') is often used during dental and other outpatient procedures, because it is easy to administer, is short-acting and rapidly clears from the body following the procedure. The investigators hypothesize that use of Nitrous oxide during GI endoscopy may enhance patient comfort during the procedure and speed-up post-procedure recovery, while minimizing the fatigue and mental fogginess some patients report the day after receiving standard sedative and narcotic drugs used routinely for the procedure. The investigators are interested in determining if adding Nitrous Oxide to commonly used sedation drugs 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.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and not pregnant.

I am scheduled for an upper endoscopy or colonoscopy with nurse-led sedation.

Patient is willing and able to consent and comply with study procedures

Exclusion Criteria

Potentially vulnerable subjects including homeless people, pregnant females, employees, and students

I am under 18 years old.

Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit

Treatment Details

Interventions

• Nitrous oxide

Trial Overview 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.

Participant Groups

Group I: 50% inhaled nitrous oxide Active Control 1 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 oxide Placebo Group 1 Intervention

Patients will received 5% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+