Sufentanil Infusion vs Sufentanil Bolus (NCT04226495) | Clinical Trial Compass
CompletedPhase 4
Sufentanil Infusion vs Sufentanil Bolus
United States65 participantsStarted 2020-10-13
Plain-language 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.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Extubation
Timeframe: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.