Stress During Deep Sedation With Propofol With and Without Alfentanil

Physiologic Stress During Procedural Sedation 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 Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Drug: propofol; Drug: alfentanil

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; propofol only for deep procedural sedation	Drug: propofol; 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
Active Comparator: Propofol/alfentanil; Propofol with alfentanil for deep procedural sedation	Drug: propofol; 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation; Drug: alfentanil; alfentanil 10 ug/kg immediately prior to propofol dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Investigators: Principal Investigator: James R. Miner, MD, Hennepin Faculty Associates

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 12, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 21, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: propofol; procedural sedation; alfentanil; stress biomarkers; Deep procedural sedation in the ED
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Alfentanil
• Other Study ID Numbers: MMRF093051