Phase 4
Completed N=126
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Source: ClinicalTrials.gov NCT00997126 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure — 11; 12 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 |
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. Informational only — not medical advice.