Stress During Deep Sedation With Propofol With and Without Alfentanil

Sedation Clinical Trial

Official title:

Physiologic Stress During Procedural Sedation With and Without Alfentanil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997113
• Other study ID #: MMRF093051
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2009
• Last updated: September 21, 2014
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• propofol
1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
• alfentanil
alfentanil 10 ug/kg immediately prior to propofol dose

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Catecholamines	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.	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	No
Secondary	Respiratory Depression	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%.	From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status	Yes
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	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.	single time point measured after sedation procedure completed	No