Stress During Deep Sedation With Propofol With and Without Alfentanil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997113
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Sedation Drug: propofol Drug: alfentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiologic Stress During Procedural Sedation With and Without Alfentanil
Study Start Date : October 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Respiratory Depression [ Time Frame: 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%.

  2. 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 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997113

United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Principal Investigator: James R. Miner, MD Hennepin Faculty Associates

Publications of Results:
Responsible Party: Minneapolis Medical Research Foundation Identifier: NCT00997113     History of Changes
Other Study ID Numbers: MMRF093051
First Posted: October 19, 2009    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Minneapolis Medical Research Foundation:
procedural sedation
stress biomarkers
Deep procedural sedation in the ED

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents