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WithdrawnNCT05396144Updated Mar 27, 2026

Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?

A Phase 4 interventional study of 5% inhaled nitrous oxide and 50% inhaled nitrous oxide in Endoscopy and Colonoscopy, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Stanford University · Phase 4, Interventional, and Treatment

Why this study was withdrawn
We do not have access to the patient population anymore due to a move in our operational design
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Endoscopy
  • Colonoscopy

Keywords

  • sedative
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non-pregnant patients age 18 and older
  • Patient's presenting for upper endoscopy or colonoscopy under endoscopist- directed nurse sedation.
  • Patient is willing and able to consent and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • Age \<18
  • Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
  • Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
  • Allergy to the proposed anesthetic agents (e.g. nitrous oxide, midazolam, fentanyl, diphenhydramine)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Sham comparator
    5% inhaled nitrous oxide

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

    Drug: 5% inhaled nitrous oxide

  • Active comparator
    50% inhaled nitrous oxide

    Patients will received 50% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.

    Drug: 50% inhaled nitrous oxide

Interventions

  • Drug5% inhaled nitrous oxide

    5% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

  • Drug50% inhaled nitrous oxide

    50% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

06

What researchers measure

Primary outcomes

  1. Intravenous sedative drug

    Tabulate the types and dosages of intravenous sedative drugs given

    Time frame: Duration of the procedure (1-2 hours)

  2. Recovery time

    Time spent in procedure room to recover

    Time frame: Duration of the procedure (1-3hours)

  3. Patient comfort

    Patient comfort rating intra-procedure using standardized scale

    Time frame: Duration of the procedure (1-3hours)

  4. Fatigue

    The number of patients who experienced fatigue

    Time frame: 24-36 hours

  5. Fatigue

    The duration of fatigue experienced, if any

    Time frame: 24-36 hours

  6. Nausea/vomiting

    Number of patients who experienced nausea/vomiting

    Time frame: 24-36 hours

  7. Nausea/vomiting

    Duration of nausea/vomiting

    Time frame: 24-36 hours

  8. Mental Fogginess post-procedure/sedation

    Duration of mental fogginess following the procedure/sedation

    Time frame: 24-36 hours

  9. Mental Fogginess post-procedure/sedation

    Number of patients who experienced mental fogginess post-procedure/sedation

    Time frame: 24-36 hours

  10. Return to baseline function

    Number of hours post-procedure/sedation for patient to return to baseline function

    Time frame: 24-36 hours

07

Study locations

1 site
  • Stanford University Hospital
    Stanford, California 94305, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05396144
Lead sponsor
Stanford University
Responsible party
Tim Angelotti (Associate Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University) — Principal investigator
First posted
May 31, 2022
Start date
May 1, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Mar 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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