Stress During Deep Sedation With Propofol With and Without Alfentanil

Study Overview
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Brief Summary
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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.

Official Title
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Physiologic Stress During Procedural Sedation With and Without Alfentanil

Conditions
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Sedation

Intervention / Treatment
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* Drug: propofol
* Drug: alfentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, alfentanil, procedural sedation, stress biomarkers, Deep procedural sedation in the ED