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

NCT05396144 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 54961
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopy; Colonoscopy

Keywords

sedative

Outcome Measures

Primary Outcomes (10)

• Intravenous sedative drug

  Tabulate the types and dosages of intravenous sedative drugs given

  Duration of the procedure (1-2 hours)

• Recovery time

  Time spent in procedure room to recover

  Duration of the procedure (1-3hours)

• Patient comfort

  Patient comfort rating intra-procedure using standardized scale

  Duration of the procedure (1-3hours)

• Fatigue

  The number of patients who experienced fatigue

  24-36 hours

• Fatigue

  The duration of fatigue experienced, if any

  24-36 hours

• Nausea/vomiting

  Number of patients who experienced nausea/vomiting

  24-36 hours

• Nausea/vomiting

  Duration of nausea/vomiting

  24-36 hours

• Mental Fogginess post-procedure/sedation

  Duration of mental fogginess following the procedure/sedation

  24-36 hours

• Mental Fogginess post-procedure/sedation

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

  24-36 hours

• Return to baseline function

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

  24-36 hours

Study Arms (2)

5% inhaled nitrous oxide

SHAM COMPARATOR

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

50% inhaled nitrous oxide

ACTIVE COMPARATOR

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

5% inhaled nitrous oxide DRUG

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

5% inhaled nitrous oxide

50% inhaled nitrous oxide DRUG

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

50% inhaled nitrous oxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Perioperative and Pain Medicine

Model Details: 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 oxide

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 31, 2022
• Study Start: May 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)