AnesthesiaPhase 4NCT04226495
Sufentanil Infusion vs Sufentanil Bolus
A Phase 4 study testing Sufentanil Infusion and Sufentanil Bolus in people with Anesthesia, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sufentanil Infusion and Sufentanil Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 28 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
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.
Read the 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).
- Conditions
- Anesthesia
- Being tested
- Sufentanil Infusion, Sufentanil Bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil InfusionDrug
Also called Sufentanil
Intra-operative sufentanil infusion
Sufentanil BolusDrug
Also called Sufentanil
Intra-operative sufentanil bolus
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil Bolus | Active comparator | medication in scheduled doses (bolus) Receives: Drug: Sufentanil Bolus |
| Sufentanil Infusion | Experimental | medication in a slow trickle (infusion) Receives: Drug: Sufentanil Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Extubation
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.
Measured: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.
Secondary outcomes (4)
Plasma Concentration
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.
Measured: Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.
Oral Morphine Milligram Equivalents
Post-operative pain medication dosage in oral morphine milligram equivalents (OMMEs).
Measured: Post-operatively
Length of ICU Stay
Duration of post-operative ICU stay in hours.
Measured: From ICU admission to ICU discharge.
Length of Hospital Stay
Length of hospitalization from hospital admission to hospital discharge measured in days.
Measured: From hospital admission to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Oct 2020
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey C Songster, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226495
- Sponsor's protocol ID
- 0520-20-FB
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2020
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04226495
- Acronym / sponsor ID
- 0520-20-FB
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil Bolus | Active comparator | Drug: Sufentanil Bolusmedication in scheduled doses (bolus) |
| Sufentanil Infusion | Experimental | Drug: Sufentanil Infusionmedication in a slow trickle (infusion) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil InfusionAlso: SufentanilIntra-operative sufentanil infusion | Drug | Sufentanil Infusion |
| Sufentanil BolusAlso: SufentanilIntra-operative sufentanil bolus | Drug | Sufentanil Bolus |
Primary outcome
Time to Extubation
Time frame: 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.
4 secondary outcomes
Plasma Concentration
Time frame: Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.
Oral Morphine Milligram Equivalents
Time frame: Post-operatively
Length of ICU Stay
Time frame: From ICU admission to ICU discharge.
Length of Hospital Stay
Time frame: From hospital admission to hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey C Songster, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil Infusion and Sufentanil Bolus in people with Anesthesia, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Extubation (time frame: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.