Evaluation of Nitrous Oxide Use in GI Endoscopy Procedures: Potential for Optimizing Sedation and Minimizing Side-Effects During Recovery
Overview
- Phase
- Phase 4
- Intervention
- Nitrous oxide
- Conditions
- Endoscopy
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intravenous sedative drug
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tim Angelotti
Associate Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University
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
- •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)
Arms & Interventions
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.
Intervention: Nitrous oxide
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.
Intervention: Nitrous oxide
Outcomes
Primary Outcomes
Intravenous sedative drug
Time Frame: Duration of the procedure (1-2 hours)
Tabulate the types and dosages of intravenous sedative drugs given
Nausea/vomiting
Time Frame: 24-36 hours
Duration of nausea/vomiting
Recovery time
Time Frame: Duration of the procedure (1-3hours)
Time spent in procedure room to recover
Patient comfort
Time Frame: Duration of the procedure (1-3hours)
Patient comfort rating intra-procedure using standardized scale
Fatigue
Time Frame: 24-36 hours
The duration of fatigue experienced, if any
Mental Fogginess post-procedure/sedation
Time Frame: 24-36 hours
Number of patients who experienced mental fogginess post-procedure/sedation
Return to baseline function
Time Frame: 24-36 hours
Number of hours post-procedure/sedation for patient to return to baseline function