Phase 4 N=20 Randomized Treatment

Stress During Deep Sedation With Propofol With and Without Alfentanil

Sedation

Bottom Line

View on ClinicalTrials.gov: NCT00997113 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Change in Serum Catecholamines — 87; 106 mcg/ml — p=0.940

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: Oct 2012

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	—

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.

Eligibility Criteria

Inclusion Criteria

patients who will require deep procedural sedation with propofol in the ED

Exclusion Criteria

age 2

View full record on ClinicalTrials.gov →

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.