Phase 4
N=107
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02404610 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry. — 22; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Moderate Procedural Sedation with a sedative medication. (Procedure); Deep Procedural Sedation with a sedative medication. (Procedure); propofol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hennepin Healthcare Research Institute
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry. |
22; 21 | — |
Summary
This study is a clinical trial of moderate sedation versus deep sedation with propofol for procedural sedation in the Emergency Department. The purpose of this study is to compare the rate of amnesia and respiratory depression rate in patients who receive moderate sedation to those that receive deep sedation.
Eligibility Criteria
Inclusion Criteria
- Adults undergoing procedural sedation with propofol in the emergency department
Exclusion Criteria
- < 18 years old
- Pregnant
- Previous allergic reaction to propofol
- Prisoner
- Unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT02404610). 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.