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We do not have access to the patient population anymore due to a move in our operational design
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% inhaled nitrous oxide | Drug | 5% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospital | Stanford | California | 94305 | United States |
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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
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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
| 50% inhaled nitrous oxide | Drug | 50% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient |
|
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 |