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Completed

NCT Number: NCT00997113

Stress During Deep Sedation With Propofol 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.

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Key information

Conditions

Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

1 mg/kg IV followed by 0.5 mg/kg iv prn sedation

alfentanil

Drug

alfentanil 10 ug/kg immediately prior to propofol dose

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

Physiologic Stress During Procedural Sedation With and Without Alfentanil

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2009
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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