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: 1

Duration: 1-3 hours

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using nitrous oxide (often called 'laughing gas') during gastrointestinal endoscopies can make the procedure more comfortable and help patients recover faster. Researchers aim to determine if it reduces fatigue, mental fogginess, and nausea compared to standard sedatives. The trial will test two different amounts of nitrous oxide alongside regular sedation. Individuals undergoing an upper endoscopy or colonoscopy who can provide consent might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients, offering participants a chance to contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for nitrous oxide?

Research has shown that nitrous oxide, or laughing gas, is generally safe for use during medical procedures like endoscopy. Studies have found it to be effective and well-tolerated. For example, nitrous oxide has been safely used during colonoscopies and other procedures to help patients feel more at ease.

Different strengths of nitrous oxide exist, and even higher strengths have been studied for safety. Side effects are rare, and nitrous oxide leaves the body quickly, reducing lingering effects like tiredness or mental fogginess.

Overall, nitrous oxide is considered a safe choice for sedation. Its rapid onset and quick dissipation help patients recover sooner after procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using nitrous oxide for sedation during endoscopy because it offers a new way to enhance patient comfort with potentially fewer side effects. Unlike traditional sedatives, which are typically administered intravenously and can lead to longer recovery times, nitrous oxide is inhaled and works quickly, allowing for a faster return to normal activities. The trial is exploring two concentrations: 5% as a sham comparator and 50% as an active comparator, to assess its effectiveness and safety compared to standard sedatives. This innovative approach could improve the overall experience for patients undergoing endoscopic procedures by providing effective sedation with a faster recovery.

What evidence suggests that nitrous oxide is effective for enhancing patient comfort during GI endoscopy?

Research has shown that nitrous oxide, also known as laughing gas, is safe and effective for endoscopy procedures. In this trial, participants will receive either 5% or 50% inhaled nitrous oxide along with standard intravenous sedatives. Studies have found that nitrous oxide aids in quick recovery with minimal issues. Patients using nitrous oxide felt less tired and mentally foggy compared to those who received stronger sedation, and they recovered faster. Overall, nitrous oxide can make procedures like colonoscopies more comfortable and speed up recovery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive nitrous oxide in addition to standard intravenous sedatives during GI endoscopy

1-3 hours

1 visit (in-person)

Recovery

Participants are monitored for recovery time and patient comfort post-procedure

1-3 hours

Follow-up

Participants are monitored for fatigue, mental fogginess, nausea/vomiting, and return to baseline function

24-36 hours

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5155184/

PMC - PubMed Central Nitrous oxide-sedated endoscopy examinations have been shown to be safe and effective, and nitrous oxide has proven a safe and effective choice for colonoscopy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05396144

Can Nitrous Oxide (Laughing Gas) be Used as a Sedative ... The investigators hypothesize that use of Nitrous oxide during GI endoscopy may enhance patient comfort during the procedure and speed-up post-procedure ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23070695

Comparison of Nitrous Oxide to No Sedation and Deep ... Compared to those deeply sedated, patients inhaling N2O had comparable diagnostic accuracy, significantly shorter procedure and recovery times, a lower risk of ...

4. giejournal.org giejournal.org/article/S0016-5107(24)03098-0/fulltext

COLONOSCOPY USING NITROUS OXIDE Conclusion. N2O can be safely used for colonoscopy and patients recover quickly with no complications.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10067734/

Nitrous oxide sedation in pediatric patients undergoing ... Good or excellent efficacy of the sedation was noted in 92% of children by the endoscopist and in 89% by the nurses. Good or excellent cooperation was noted in ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/nitrous-oxide-laughing-gas

Nitrous Oxide (Laughing Gas): Uses, Side Effects & Safety Nitrous oxide (laughing gas) is a sedative healthcare providers use to keep you comfortable during procedures. It's a colorless, faintly sweet-smelling gas.

7. apsf.org apsf.org/article/safety-and-utility-of-nitrous-oxide-for-labor-analgesia/

Safety and Utility of Nitrous Oxide for Labor Analgesia The National Institute of Occupational Safety and Health recommends a maximal time-weighted average level of exposure to nitrous oxide of no more than 25 ppm ...

8. sedationsystems.com sedationsystems.com/wp-content/uploads/No.3ZIERSafety_of_High_Concentration_Nitrous_Oxide_by.11.pdf

Safety of High-Concentration Nitrous Oxide by Nasal Mask ... Adverse event data were collected using a quality audit tool designed to assess the safety of N2O for procedural sedation. This tool was modeled after one ...