Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?
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 |
---|---|---|
|
Phase 4 |
Study Design
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
- Intravenous sedative drug [Duration of the procedure (1-2 hours)]
Tabulate the types and dosages of intravenous sedative drugs given
- 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 number of patients who experienced fatigue
- Fatigue [24-36 hours]
The duration of fatigue experienced, if any
- Nausea/vomiting [24-36 hours]
Number of patients who experienced nausea/vomiting
- Nausea/vomiting [24-36 hours]
Duration of nausea/vomiting
- Mental Fogginess post-procedure/sedation [24-36 hours]
Duration of mental fogginess following the procedure/sedation
- 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
Eligibility Criteria
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)
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.- 54961