N/A
N=40
Probability Ramp Control of Propofol for EGD
Gastrointestinal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01838304 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants Requiring Adjustment in Propofol Dosing — 16; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Probability ramp control (Device); Monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Requiring Adjustment in Propofol Dosing |
16; 2 | — |
| SECONDARY Decrease in Minute Ventilation From Baseline |
25; 50 | — |
| SECONDARY Time Spent Below a Saturation of 80% |
168; 22 | <0.0001 sig |
| SECONDARY Procedure Time |
9.03; 8.9 | — |
Summary
Endoscopic sedation requires titration of propofol to deep sedation without minimum overshoot into general anesthesia. This skill is demanding and acquired slowly. Probability Ramp Control (PRC) simplifies this by providing the clinician with a simple infusion sequence that permits gradual titration of propofol. The purpose of this study is to compare the performance of this technology to that of experienced anesthesia providers in endoscopic sedation.
Eligibility Criteria
Inclusion Criteria
- scheduled for elective EGD
Exclusion Criteria
- Unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01838304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.