Using nitrous oxide as a sedative for GI endoscopy procedures
Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery
PHASE4 · Stanford University · NCT05396144
This study is testing if using nitrous oxide, or 'laughing gas', as a sedative during GI endoscopy procedures can make patients feel more comfortable and recover faster.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05396144 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of nitrous oxide, commonly known as 'laughing gas', as a sedative during gastrointestinal endoscopy procedures such as colonoscopy. The study aims to enhance patient comfort and expedite recovery by minimizing the fatigue and mental fogginess associated with traditional sedatives. Participants will receive nitrous oxide in conjunction with standard sedation drugs, and the study will assess its effects on post-procedure recovery, including nausea and overall mental clarity. The goal is to determine if this approach can improve the patient experience during and after the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are non-pregnant adults aged 18 and older who are scheduled for upper endoscopy or colonoscopy.
Not a fit: Patients under 18, pregnant individuals, or those with allergies to the anesthetic agents used in the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to a more comfortable and quicker recovery for patients undergoing GI endoscopy procedures.
How similar studies have performed: Other studies have shown positive outcomes using nitrous oxide in outpatient procedures, suggesting potential success for this novel application in GI endoscopy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Stanford, California
- Stanford University Hospital — Stanford, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endoscopy, Colonoscopy, sedative