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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05396144
Collaborator
(none)
100
1
2
23
4.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitrous oxide
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to either receive 5% or 50% inhaled nitrous oxide in addition to typical sedative agents which will be given at the direction of the doctor performing the procedure. There is a 50% chance you will be assigned to receive either 5% or 50% nitrous oxidePatients will be randomized to either receive 5% or 50% inhaled nitrous oxide in addition to typical sedative agents which will be given at the direction of the doctor performing the procedure. There is a 50% chance you will be assigned to receive either 5% or 50% nitrous oxide
Masking:
Double (Participant, Care Provider)
Masking Description:
The patient and healthcare providers (e.g. gastroenterologist performing the procedure and nurse administering conscious sedation) will not know if the patient is receiving either 5% or 50% inhaled nitrous oxide
Primary Purpose:
Treatment
Official Title:
Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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: Nitrous oxide
Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

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

Outcome Measures

Primary Outcome Measures

  1. Intravenous sedative drug [Duration of the procedure (1-2 hours)]

    Tabulate the types and dosages of intravenous sedative drugs given

  2. Recovery time [Duration of the procedure (1-3hours)]

    Time spent in procedure room to recover

  3. Patient comfort [Duration of the procedure (1-3hours)]

    Patient comfort rating intra-procedure using standardized scale

  4. Fatigue [24-36 hours]

    The number of patients who experienced fatigue

  5. Fatigue [24-36 hours]

    The duration of fatigue experienced, if any

  6. Nausea/vomiting [24-36 hours]

    Number of patients who experienced nausea/vomiting

  7. Nausea/vomiting [24-36 hours]

    Duration of nausea/vomiting

  8. Mental Fogginess post-procedure/sedation [24-36 hours]

    Duration of mental fogginess following the procedure/sedation

  9. Mental Fogginess post-procedure/sedation [24-36 hours]

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

  10. Return to baseline function [24-36 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Hospital Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tim Angelotti, Associate Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT05396144
Other Study ID Numbers:
  • 54961
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Tim Angelotti, Associate Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022