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Stress During Deep Sedation With Propofol With and Without Alfentanil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00997113
First received: October 12, 2009
Last updated: September 21, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Sedation
Drug: propofol
Drug: alfentanil
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997113

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

Publications:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997113     History of Changes
Other Study ID Numbers: MMRF093051
Study First Received: October 12, 2009
Results First Received: March 28, 2014
Last Updated: September 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alfentanil
Propofol
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014