Physiologic Stress During Procedural Sedation With and Without Alfentanil
Overview
- Phase
- Phase 4
- Intervention
- propofol
- Conditions
- Sedation
- Sponsor
- Hennepin Healthcare Research Institute
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Serum Catecholamines
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients who will require deep procedural sedation with propofol in the ED
Exclusion Criteria
- •intoxication
- •unable to provide informed consent
- •allergy to propofol or alfentanil
- •ASA physical status score \> 2
Arms & Interventions
Propofol
propofol only for deep procedural sedation
Intervention: propofol
Propofol/alfentanil
Propofol with alfentanil for deep procedural sedation
Intervention: propofol
Propofol/alfentanil
Propofol with alfentanil for deep procedural sedation
Intervention: alfentanil
Outcomes
Primary Outcomes
Change in Serum Catecholamines
Time Frame: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes
change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.
Secondary Outcomes
- Respiratory Depression(From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status)
- 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(single time point measured after sedation procedure completed)