Stress During Deep Sedation With Propofol With and Without Alfentanil

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: propofol; Drug: alfentanil

• Registration Number: NCT00997113
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-12
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Results First Submitted: 2014-03-28
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-21
• Last Update Submitted: 2014-09-21
• Results First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• age <18
• intoxication
• unable to provide informed consent
• allergy to propofol or alfentanil
• pregnant
• ASA physical status score > 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	propofol	propofol only for deep procedural sedation
Propofol/alfentanil	propofol	Propofol with alfentanil for deep procedural sedation
Propofol/alfentanil	alfentanil	Propofol with alfentanil for deep procedural sedation

Primary Outcome Measures

Name	Time	Method
Change in Serum Catecholamines	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 Outcome Measures

Name	Time	Method
Respiratory Depression	From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status	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	single time point measured after sedation procedure completed	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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States