Clinical trial NCT05396144: Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?
Official title: Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endoscopy
Colonoscopy
Keywords: sedative
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Intravenous sedative drug
timeFrame: Duration of the procedure (1-2 hours)
measure: Recovery time
timeFrame: Duration of the procedure (1-3hours)
measure: Patient comfort
timeFrame: Duration of the procedure (1-3hours)
measure: Fatigue
timeFrame: 24-36 hours
measure: Fatigue
timeFrame: 24-36 hours
measure: Nausea/vomiting
timeFrame: 24-36 hours
measure: Nausea/vomiting
timeFrame: 24-36 hours
measure: Mental Fogginess post-procedure/sedation
timeFrame: 24-36 hours
measure: Mental Fogginess post-procedure/sedation
timeFrame: 24-36 hours
measure: Return to baseline function
timeFrame: 24-36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
References: