Anesthesia
Conditions
Brief 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.
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).
Interventions
DRUGSufentanil Infusion
Intra-operative sufentanil infusion
DRUGSufentanil Bolus
Intra-operative sufentanil bolus
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration | Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure. | 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. |
| Oral Morphine Milligram Equivalents | Post-operatively | Post-operative pain medication dosage in oral morphine milligram equivalents (OMMEs). |
| Length of ICU Stay | From ICU admission to ICU discharge. | Duration of post-operative ICU stay in hours. |
| Length of Hospital Stay | From hospital admission to hospital discharge | Length of hospitalization from hospital admission to hospital discharge measured in days. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey C Songster, MD
University of Nebraska
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sufentanil Bolus Sufentanil Bolus: Intra-operative sufentanil bolus | 32 |
| Sufentanil Infusion Sufentanil Infusion: Intra-operative sufentanil infusion | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | Sufentanil Bolus | Sufentanil Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Continuous | 64.9 years STANDARD_DEVIATION 8.4 | 63.3 years STANDARD_DEVIATION 8.9 | 64.1 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 32 participants | 33 participants | 65 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 4 / 24 | 5 / 24 |
| serious Total, serious adverse events | 1 / 24 | 1 / 24 |
Outcome results
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.
Time frame: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.
Population: The participant number represent the number of participant whom made it to this portion of the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sufentanil Bolus | Time to Extubation | 230.5 Minutes |
| Sufentanil Infusion | Time to Extubation | 242.4 Minutes |
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.
Time frame: Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sufentanil Bolus | Plasma Concentration | 2.8 ng/mL | Standard Deviation 0.5 |
| Sufentanil Infusion | Plasma Concentration | 2.8 ng/mL | Standard Deviation 0.5 |