Stress During Deep Sedation With Propofol With and Without Alfentanil
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Physiologic Stress During Procedural Sedation With and Without Alfentanil|
- 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 ] [ Designated as safety issue: No ]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.
- Respiratory Depression [ Time Frame: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status ] [ Designated as safety issue: Yes ]categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.
- 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 [ Time Frame: single time point measured after sedation procedure completed ] [ Designated as safety issue: No ]Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.
|Study Start Date:||October 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Propofol
propofol only for deep procedural sedation
1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
Active Comparator: Propofol/alfentanil
Propofol with alfentanil for deep procedural sedation
1 mg/kg IV followed by 0.5 mg/kg iv prn sedationDrug: alfentanil
alfentanil 10 ug/kg immediately prior to propofol dose
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997113
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||James R. Miner, MD||Hennepin Faculty Associates|