Colonoscopy, Endoscopy
Conditions
Keywords
sedative
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.
Interventions
DRUG5% inhaled nitrous oxide
5% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient
DRUG50% inhaled nitrous oxide
50% Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Nausea/vomiting | 24-36 hours | Number of patients who experienced nausea/vomiting |
| Mental Fogginess post-procedure/sedation | 24-36 hours | Duration of mental fogginess following the procedure/sedation |
| Return to baseline function | 24-36 hours | Number of hours post-procedure/sedation for patient to return to baseline function |
Countries
United States
Outcome results
None listed