Phase 4 N=65 Randomized Single-blind Treatment

Sufentanil Infusion vs Sufentanil Bolus

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT04226495 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Feb 2023

Primary outcome: Primary: Time to Extubation — 230.5; 242.4 Minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sufentanil Infusion (Drug); Sufentanil Bolus (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Extubation	230.5; 242.4	—
SECONDARY Plasma Concentration	2.8; 2.8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04226495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.