Sufentanil Infusion vs Sufentanil Bolus

University of Nebraska

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Sufentanil Bolus; Drug: Sufentanil Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04226495

0520-20-FB

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Sufentanil Bolus

Active Comparator group

Description:

medication in scheduled doses (bolus)

Treatment:

Drug: Sufentanil Bolus

Sufentanil Infusion

Experimental group

Description:

medication in a slow trickle (infusion)

Treatment:

Drug: Sufentanil Infusion