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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endoscopy, Colonoscopy

Intervention / Treatment
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* Drug: Nitrous oxide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 5% inhaled nitrous oxide<br>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<br>* Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient<br>|
| Active Comparator: 50% inhaled nitrous oxide<br>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<br>* Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedative