Phase 4
Completed N=20
Stress During Deep Sedation With Propofol With and Without Alfentanil
Source: ClinicalTrials.gov NCT00997113 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Change in Serum Catecholamines — 87; 106 mcg/ml — p=0.940
Summary
This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Catecholamines |
87; 106 | 0.940 |
| SECONDARY Respiratory Depression |
4; 5 | — |
| SECONDARY Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure |
2; 5 | — |
Eligibility Criteria
Inclusion Criteria
- patients who will require deep procedural sedation with propofol in the ED
Exclusion Criteria
- age 2
Data sourced from ClinicalTrials.gov (NCT00997113). 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.