Sufentanil Infusion vs Sufentanil Bolus

Study Overview
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Brief Summary
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Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.

Detailed Description
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This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).

Official Title
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Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sufentanil Infusion
* Drug: Sufentanil Bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR 19 to 80 years old Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit. Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case Exclusion Criteria: Sufentanil allergy EF less than or equal to 30% Moderate or severe right ventricular dysfunction, Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy. End Stage Renal Disease on Dialysis Chronic Kidney Disease with GFR <30 Sternotomy Re-do Emergency surgery Greater than 4 units of RBCs or FFP combined Mechanical circulatory support post-operatively such as ECMO, IABP, Impella Not eligible for rapid wean extubation protocol Requires infusion of sedative medication required during ICU admission Greater than or equal to 15 minute ICU hold within PACU

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sufentanil Bolus<br>medication in scheduled doses (bolus) | Drug: Sufentanil Bolus<br>* Intra-operative sufentanil bolus<br>* Other names: Sufentanil;|
| Experimental: Sufentanil Infusion<br>medication in a slow trickle (infusion) | Drug: Sufentanil Infusion<br>* Intra-operative sufentanil infusion<br>* Other names: Sufentanil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Extubation | We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation from OR stop data collection time point by 60 minutes compared to sufentanil bolus administration. | Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration | We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will result in a lower plasma concentration of sufentanil at time of arrival to ICU and if the plasma concentration correlates with time to extubation. | Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure. |