Stress During Deep Sedation With Propofol With and Without Alfentanil

Hennepin Healthcare Research Institute20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sedation

Interventions

propofolDRUG

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

alfentanilDRUG

alfentanil 10 ug/kg immediately prior to propofol dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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%.

Time frame: 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.

Time frame: single time point measured after sedation procedure completed

Data from ClinicalTrials.gov

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