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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil Bolus | Active Comparator | medication in scheduled doses (bolus) |
|
| Sufentanil Infusion | Experimental | medication in a slow trickle (infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil Infusion | Drug | Intra-operative sufentanil infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey C Songster, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil Bolus | Sufentanil Bolus: Intra-operative sufentanil bolus |
| FG001 | Sufentanil Infusion | Sufentanil Infusion: Intra-operative sufentanil infusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil Bolus | Sufentanil Bolus: Intra-operative sufentanil bolus |
| BG001 | Sufentanil Infusion | Sufentanil Infusion: Intra-operative sufentanil infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The participant number represent the number of participant whom made it to this portion of the study. | Posted | Mean | Full Range | Minutes | Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes. |
|
Procedure end time to discharge from hospital, an average of 4 days.
AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship.
Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sufentanil Bolus | Sufentanil Bolus: Intra-operative sufentanil bolus | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left MCA stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment | Hypotension requiring vasopressor support in ICU. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Songster | University of Nebraska Medical Center | 308-520-2847 | jeffrey.songster@unmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2020 | Jan 11, 2023 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2021 | Nov 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sufentanil Bolus | Drug | Intra-operative sufentanil bolus |
|
|
| Oral Morphine Milligram Equivalents | Post-operative pain medication dosage in oral morphine milligram equivalents (OMMEs). | Post-operatively |
| Length of ICU Stay | Duration of post-operative ICU stay in hours. | From ICU admission to ICU discharge. |
| Length of Hospital Stay | Length of hospitalization from hospital admission to hospital discharge measured in days. | From hospital admission to hospital discharge |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | 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. | Lab concentration was measured on arrival to ICU. Not all subjects had this lab available, thus the inconsistency of numbers from the participant flow module. | Posted | Mean | Standard Deviation | ng/mL | Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure. |
|
|
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| Secondary | Oral Morphine Milligram Equivalents | Post-operative pain medication dosage in oral morphine milligram equivalents (OMMEs). | Oral Morphine Milligram Equivalents were measured in all participants with postoperative data through hospital discharge. | Posted | Mean | Standard Deviation | OMME | Post-operatively |
|
|
|
| Secondary | Length of ICU Stay | Duration of post-operative ICU stay in hours. | The participant number represent the number of participant whom made it to this portion of the study. | Posted | Mean | Standard Deviation | Hours | From ICU admission to ICU discharge. |
|
|
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| Secondary | Length of Hospital Stay | Length of hospitalization from hospital admission to hospital discharge measured in days. | The analysis population included all participants with hospitalization data through hospital discharge. | Posted | Mean | Standard Deviation | Days | From hospital admission to hospital discharge |
|
|
|
| 24 |
| 1 |
| 24 |
| 4 |
| 24 |
| EG001 | Sufentanil Infusion | Sufentanil Infusion: Intra-operative sufentanil infusion | 0 | 24 | 1 | 24 | 5 | 24 |
| Emergent OR procedure | Cardiac disorders | Systematic Assessment | Return to OR for bleeding. |
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| Gross Hematuria | Renal and urinary disorders | Systematic Assessment | Grade 3 |
|
| Acute blood loss anemia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3 |
|
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