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

Colonoscopy Clinical Trial

Official title:

Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396144
• Other study ID #: 54961
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colonoscopy
• Endoscopy

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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