Sufentanil Infusion vs Sufentanil Bolus

Phase 4

Completed

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sufentanil Infusion	Sufentanil Infusion	medication in a slow trickle (infusion)
Sufentanil Bolus	Sufentanil Bolus	medication in scheduled doses (bolus)

Primary Outcome Measures

Name	Time	Method
Time to Extubation	Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration	Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.	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.