Sedative During Endoscopy
Conditions
Keywords
GERD, Dyspepsia, screening colonoscopy, diagnostic upper endoscopy, Gastroesophageal reflux disease
Brief summary
The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.
Interventions
DEVICEPico 4 Enterprise headset with noise cancelling headphones
The device includes a computer tablet and virtual reality headset.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
INTERVENTION GROUP Inclusion Criteria: * Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital * Aged 21 to 65
Exclusion criteria
* Visual impairments such as blindness which would impair them from watching the entertainment videos. * Patients with history of CAD, * History of seizures, * History of vertigo, * History of allergy to plastic, * ASAII or III, * Patient with active GI bleed, having either melena or hematochezia. CONTROL GROUP Inclusion Criteria: * Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital * Aged 21 to 65
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of sedative drugs administered during the procedure | End of procedure, up to 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported discomfort or pain (using 0-10 pain scale) | During PACU stay, approximately 30 minutes | — |
| Duration of the procedure | End of procedure, up to 1 hour | — |
| Overall patient satisfaction scores | During PACU stay, approximately 30 minutes | Using Likert scale of 1-7. Subjects will be asked to rank several variables on the Likert scale, including overall experience (from 1-very dissatisfied to 7-very satisfied), enjoyability (from 1- not enjoyable to 7-very enjoyable), and anxiety (from 1-extreme anxiety to 7-no anxiety). Scores range from 3-21, higher scores indicate satisfaction. |
| Number of events of complications from VR | During PACU stay, approximately 30 minutes | Events such as nausea, vomiting, dizziness. |
| Number of technical failures | End of procedure, up to 1 hour | — |
| Troubleshooting time | End of procedure, up to 1 hour | — |
| PACU length of stay | End of PACU stay, approximately 30 minutes | — |
Countries
United States
Contacts
CONTACTMaysaa El Zoghbi, MD
CONTACTGregory Faulx
PRINCIPAL_INVESTIGATORMaysaa El Zoghbi, MD
NYU Langone Health
Outcome results
None listed