Phase 4
N=126
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Sedation
Bottom Line
View on ClinicalTrials.gov: NCT00997126 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure — 11; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propofol (Drug); Alfentanil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hennepin Healthcare Research Institute
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure |
11; 12 | — |
| SECONDARY Time to Return of Baseline Mental Status From Start of Procedure in Minutes |
13; 13 | — |
| SECONDARY Depth of Sedation Measured Using the OAAS Scale |
2; 3 | — |
| SECONDARY Patient Reported Pain |
7; 25 | — |
| SECONDARY Patient Reported Recall of the Procedure |
13; 39 | 0.657 |
Summary
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).
Eligibility Criteria
Inclusion Criteria
- Adults undergoing moderate procedural sedation in the Emergency Department
Exclusion Criteria
- Age 2
- Patients who require deep procedural sedation
Data sourced from ClinicalTrials.gov (NCT00997126). 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.