Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
Phase: PHASE4
Conditions: Anesthesia
Sponsor: University of Nebraska

COVER SHEET 
Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac Surgery 
NCT # 04226495 
September 30, 2020 

 
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Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac Surgery 
Study Chairman or Principal Investigator: 
 
Jeffrey Songster, MD 
Assistant Professor, Department of Anesthesiology 
University of Nebraska Medical Center 
Supported by: 
 
Department of Anesthesiology 
University of Nebraska Medical Center 
 
Study Intervention Provided by: 
No support from pharmaceutical company or device manufacture. 
NCT Number: 
NCT # 04226495 
 
 
 
 
 
 
 
 
 
 
 

 
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PRÉCIS 
Study Title  
Sufentanil Infusion vs. Sufentanil Bolus and Time to Extubation during Routine Cardiac 
Surgery  
Hypothesis  
We hypothesize 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 patients receiving sufentanil bolus dosing even with similar total doses 
of sufentanil. 
Objectives  
Primary Outcome: Time the subject becomes extubated from stop data collection time 
point within the EMR. 
 
Secondary Outcome: Plasma Sufentanil concentrations, Sufentanil pharmacokinetics,  
24 hour post-operative pain scores, 24 hour opioid requirements in morphine equivalents, 
vasopressors and inotropes usage, ICU length of stay, Hospital length of stay, early re-
intubation rate. 
Design and Outcomes   
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. 
 
Interventions and Duration: 
Intervention period: intra-operative sufentanil infusion vs intermittent bolus dosing the 
intervention will stop at the stop data collection time point within the operating room.  
 
Post Intervention: Multiple lab draws at various time points to assess sufentanil 
concentrations and pharmacokinetics, we will follow pain scores and opioid requirements 
for 24 hours post intervention, we will follow the patient until discharge from the hospital 
for ICU length of stay and hospital length of stay. No further follow up after discharge. 
We anticipate a 24-48 hour ICU length of stay and a 5-7 day hospital length of stay. 
  
Sample Size and Population  
Adults between ages 19 and 80 with reasonable cardiac and pulmonary function 
presenting for routine cardiac surgery including coronary artery bypass graft and aortic 
valve replacement who qualify for “fast track extubation”. Based on estimates for time to 
extubation for our study population on sufentanil bolus dosing where we have an average 
time to extubation of 190.5 minutes (SD = 99 min) and assuming 80% power and 
statistical significance alpha level of 0.05, our power analysis suggests that we would 

 
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need to recruit at least 43 subjects into each intervention group for a total of 86 subjects 
giving the ability to detect a 60 min difference in time to extubation between groups. We 
plan on inflating this number to at least 100 subjects with approximately 50 subjects in 
each arm to allow for potential minimal losses in evaluable patients associated with 
unforeseen attrition related to exclusion criteria and censoring due to death or severely