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

Phase 4

Recruiting

• Conditions: Endoscopy; Colonoscopy
• Interventions: Drug: Nitrous oxide

• Registration Number: NCT05396144
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Study Start: 2024-05-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% inhaled nitrous oxide	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.
50% inhaled nitrous oxide	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.

Primary Outcome Measures

Name	Time	Method
Intravenous sedative drug	Duration of the procedure (1-2 hours)	Tabulate the types and dosages of intravenous sedative drugs given
Nausea/vomiting	24-36 hours	Duration of nausea/vomiting
Recovery time	Duration of the procedure (1-3hours)	Time spent in procedure room to recover
Patient comfort	Duration of the procedure (1-3hours)	Patient comfort rating intra-procedure using standardized scale
Fatigue	24-36 hours	The duration of fatigue experienced, if any
Mental Fogginess post-procedure/sedation	24-36 hours	Number of patients who experienced mental fogginess post-procedure/sedation
Return to baseline function	24-36 hours	Number of hours post-procedure/sedation for patient to return to baseline function

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States