Trial Outcomes & Findings for Measures to Lower the Stress Response in Pediatric Cardiac Surgery (NCT NCT00848393)
NCT ID: NCT00848393
Last Updated: 2018-07-27
Results Overview
N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.
Results posted on
2018-07-27
Participant Flow
A total of 51 study subjects completed the study.
Total number of subjects recruited was 52 patients (one enrollee withdrew prior to any study-related procedures) resulting in a total number of subjects participating of 51. The enrollee was withdrawn from the study after signing the consent and prior to enrolling to one of the arms of the study.
Participant milestones
| Measure |
Fentanyl (High Dose)
Patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
Fentanyl (Low Dose)
Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1 mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1 mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5 mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
18
|
|
Overall Study
COMPLETED
|
17
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Fentanyl (High Dose)
Patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
Fentanyl (Low Dose)
Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10 mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
Patients in this arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1 mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1 mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5 mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
surgical complications unrelated to stud
|
0
|
0
|
2
|
Baseline Characteristics
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Fentanyl (High Dose)
n=17 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
Fentanyl (Low Dose)
n=16 Participants
patients in this group will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=15 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
4 months
n=5 Participants
|
4 months
n=7 Participants
|
5 months
n=5 Participants
|
4 months
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α.
Outcome measures
| Measure |
Fentanyl (Low Dose)
n=16 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=15 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=17 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
ACTH and Cytokine Levels
Post-Bypass ACTH (pg/mL)
|
172.7 pg/mL
Standard Deviation 121.8
|
191.6 pg/mL
Standard Deviation 220.2
|
57.2 pg/mL
Standard Deviation 61.2
|
|
ACTH and Cytokine Levels
24 hour Post-Surgery IL-10 (pg/mL)
|
14.80833 pg/mL
Standard Deviation 10.65888
|
9.692857 pg/mL
Standard Deviation 0.775058
|
10.80667 pg/mL
Standard Deviation 1.907304
|
|
ACTH and Cytokine Levels
Baseline ACTH (pg/mL)
|
182.7 pg/mL
Standard Deviation 111.3
|
135.3 pg/mL
Standard Deviation 129.8
|
116.9 pg/mL
Standard Deviation 117.0
|
|
ACTH and Cytokine Levels
Post-Sternotomy ACTH (pg/mL)
|
86.2 pg/mL
Standard Deviation 76.5
|
106.9 pg/mL
Standard Deviation 153.5
|
44.5 pg/mL
Standard Deviation 39.7
|
|
ACTH and Cytokine Levels
End-Of-Surgery ACTH (pg/mL)
|
155.0 pg/mL
Standard Deviation 107.5
|
154.1 pg/mL
Standard Deviation 166.6
|
66.4 pg/mL
Standard Deviation 77.9
|
|
ACTH and Cytokine Levels
24 hour Post-Surgery ACTH (pg/mL)
|
53.2 pg/mL
Standard Deviation 24.3
|
22.4 pg/mL
Standard Deviation 130.3
|
12.7 pg/mL
Standard Deviation 7.4
|
|
ACTH and Cytokine Levels
Baseline TNF-alpha (pg/mL)
|
25.294 pg/mL
Standard Deviation 31.22396
|
8.018182 pg/mL
Standard Deviation 10.68364
|
15.70077 pg/mL
Standard Deviation 16.401
|
|
ACTH and Cytokine Levels
Post-Sternotomy TNF-alpha (pg/mL)
|
24.497 pg/mL
Standard Deviation 33.8474
|
17.88636 pg/mL
Standard Deviation 16.96651
|
26.51846 pg/mL
Standard Deviation 33.64902
|
|
ACTH and Cytokine Levels
Post-Bypass TNF-alpha (pg/mL)
|
25.787 pg/mL
Standard Deviation 29.267
|
20.34364 pg/mL
Standard Deviation 14.03041
|
24.30615 pg/mL
Standard Deviation 23.03753
|
|
ACTH and Cytokine Levels
End-Of-Surgery TNF-alpha (pg/mL)
|
24.857 pg/mL
Standard Deviation 18.82328
|
23.06091 pg/mL
Standard Deviation 18.8737
|
23.87077 pg/mL
Standard Deviation 17.18903
|
|
ACTH and Cytokine Levels
24 hour Post-Surgery TNF-alpha (pg/mL)
|
11.954 pg/mL
Standard Deviation 17.23623
|
21.13909 pg/mL
Standard Deviation 19.00043
|
15.79 pg/mL
Standard Deviation 30.8563
|
|
ACTH and Cytokine Levels
Baseline IL-6 (pg/mL)
|
4.757142857 pg/mL
Standard Deviation 2.178819118
|
5.542857143 pg/mL
Standard Deviation 3.455366904
|
6.637058824 pg/mL
Standard Deviation 4.356124661
|
|
ACTH and Cytokine Levels
Post-Sternotomy IL-6 (pg/mL)
|
12.17333 pg/mL
Standard Deviation 28.79942
|
6.241333 pg/mL
Standard Deviation 4.0798
|
5.402353 pg/mL
Standard Deviation 3.623996
|
|
ACTH and Cytokine Levels
Post-Bypass IL-6 (pg/mL)
|
5.509375 pg/mL
Standard Deviation 3.93354
|
5.040667 pg/mL
Standard Deviation 2.583747
|
5.098824 pg/mL
Standard Deviation 3.10355
|
|
ACTH and Cytokine Levels
End-Of-Surgery IL-6 (pg/mL)
|
22.47333 pg/mL
Standard Deviation 12.59657
|
20.79231 pg/mL
Standard Deviation 12.55537
|
20.48571 pg/mL
Standard Deviation 11.00962
|
|
ACTH and Cytokine Levels
24 hour Post-Surgery IL-6 (pg/mL)
|
117.975 pg/mL
Standard Deviation 95.86805
|
142.1571 pg/mL
Standard Deviation 129.4279
|
126.0813 pg/mL
Standard Deviation 141.7456
|
|
ACTH and Cytokine Levels
Baseline IL-8 (pg/mL)
|
10.44286 pg/mL
Standard Deviation 1.839195
|
10.25714 pg/mL
Standard Deviation 1.336306
|
17.12353 pg/mL
Standard Deviation 24.88048
|
|
ACTH and Cytokine Levels
Post-Sternotomy IL-8 (pg/mL)
|
10.66667 pg/mL
Standard Deviation 2.941736
|
10.86667 pg/mL
Standard Deviation 1.980861
|
20.77647 pg/mL
Standard Deviation 42.23163
|
|
ACTH and Cytokine Levels
Post-Bypass IL-8 (pg/mL)
|
10.13125 pg/mL
Standard Deviation 2.15769
|
9.673333 pg/mL
Standard Deviation 1.182894
|
9.770588 pg/mL
Standard Deviation 2.389499
|
|
ACTH and Cytokine Levels
End-Of-Surgery IL-8 (pg/mL)
|
33.12667 pg/mL
Standard Deviation 25.1446
|
37.22143 pg/mL
Standard Deviation 43.66227
|
28.1 pg/mL
Standard Deviation 17.28596
|
|
ACTH and Cytokine Levels
24 hour Post-Surgery IL-8 (pg/mL)
|
47.25 pg/mL
Standard Deviation 99.4908
|
24.27143 pg/mL
Standard Deviation 14.72541
|
49.07143 pg/mL
Standard Deviation 69.39429
|
|
ACTH and Cytokine Levels
Baseline IL-10 (pg/mL)
|
9.9 pg/mL
Standard Deviation 0.00000
|
12.76429 pg/mL
Standard Deviation 9.373252
|
10.82353 pg/mL
Standard Deviation 1.952412
|
|
ACTH and Cytokine Levels
Post-Sternotomy IL-10 (pg/mL)
|
9.9 pg/mL
Standard Deviation 0.00000
|
14.10667 pg/mL
Standard Deviation 13.63863
|
9.911765 pg/mL
Standard Deviation 2.749291
|
|
ACTH and Cytokine Levels
Post-Bypass IL-10 (pg/mL)
|
9.9 pg/mL
Standard Deviation 2.581989
|
12.30667 pg/mL
Standard Deviation 10.78136
|
9.488235 pg/mL
Standard Deviation 1.872793
|
|
ACTH and Cytokine Levels
End-Of-Surgery IL-10 (pg/mL)
|
325.55 pg/mL
Standard Deviation 262.3603
|
569.2714 pg/mL
Standard Deviation 858.2538
|
345.4412 pg/mL
Standard Deviation 445.7443
|
PRIMARY outcome
Timeframe: Hospital admission to discharge from CTICU (average of 2-4 days)Outcome measures
| Measure |
Fentanyl (Low Dose)
n=16 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=15 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=17 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.
|
1 Days
Interval 1.0 to 4.0
|
2 Days
Interval 1.0 to 5.0
|
1 Days
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Time of intubation to extubation (variable)Outcome measures
| Measure |
Fentanyl (Low Dose)
n=16 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=15 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=17 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.
|
3.79 Hours
Interval 0.0 to 16.0
|
2.4 Hours
Interval 0.0 to 2.4
|
10.75 Hours
Interval 0.0 to 27.32
|
PRIMARY outcome
Timeframe: 1-4 yrs. post-surgeryPopulation: Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.
The Stanford-Binet test evaluates the overall IQ score from the assessment of cognitive ability. The test consists of 15 subtests, grouped into the four area scores. Six subtests are administered to all age levels. The subtests are: Vocabulary, Comprehension, Pattern Analysis, Quantitative, Bead Memory, and Memory for Sentences. Number of tests administered and test difficulty are based on the test taker's age and performance on subtest measuring word knowledge. The word knowledge subtest is given to all test takers and is the first subtest administered. A score of 100 is in the normal or average range. Higher scores suggest a higher level of functioning related to each category. (University of Cincinnati, 2003) Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150).
Outcome measures
| Measure |
Fentanyl (Low Dose)
n=9 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=7 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=5 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
Stanford-Binet Intelligence Scales
Nonverbal IQ composite score
|
98 IQ
Standard Deviation 15
|
89 IQ
Standard Deviation 6
|
92 IQ
Standard Deviation 19
|
|
Stanford-Binet Intelligence Scales
Verbal IQ composite score
|
91 IQ
Standard Deviation 17
|
80 IQ
Standard Deviation 8
|
93 IQ
Standard Deviation 26
|
|
Stanford-Binet Intelligence Scales
Full-scale IQ composite score
|
94 IQ
Standard Deviation 15
|
83 IQ
Standard Deviation 5
|
93 IQ
Standard Deviation 24
|
PRIMARY outcome
Timeframe: Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.Cortisol, epinephrine, and norepinephrine assayed by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Fentanyl (Low Dose)
n=16 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=15 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=17 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
Stress Hormone Levels
Baseline Norepinephrine
|
19.34153 ng/mL
Standard Deviation 9.880667
|
19.45968 ng/mL
Standard Deviation 13.08422
|
13.32618 ng/mL
Standard Deviation 10.1541
|
|
Stress Hormone Levels
Post-Sternotomy Norepinephrine
|
17.08766 ng/mL
Standard Deviation 8.419782
|
12.74458 ng/mL
Standard Deviation 11.4669
|
16.2606 ng/mL
Standard Deviation 9.929948
|
|
Stress Hormone Levels
Post-Bypass Norepinephrine
|
22.31064 ng/mL
Standard Deviation 17.06955
|
19.73612 ng/mL
Standard Deviation 17.07041
|
23.35796 ng/mL
Standard Deviation 13.54953
|
|
Stress Hormone Levels
End-of-Surgery Norepinephrine
|
10.74731 ng/mL
Standard Deviation 8.144776
|
7.727055 ng/mL
Standard Deviation 13.04373
|
11.22376 ng/mL
Standard Deviation 8.599634
|
|
Stress Hormone Levels
24 hour Post-Surgery Norepinephrine
|
20.85433 ng/mL
Standard Deviation 18.38192
|
26.67379 ng/mL
Standard Deviation 26.06332
|
19.03031 ng/mL
Standard Deviation 17.41692
|
|
Stress Hormone Levels
Baseline ephinephrine
|
6.439221 ng/mL
Standard Deviation 7.528216
|
5.876335 ng/mL
Standard Deviation 9.551871
|
2.7848 ng/mL
Standard Deviation 3.127335
|
|
Stress Hormone Levels
Post-Sternotomy Epinephrine
|
9.843591 ng/mL
Standard Deviation 8.670264
|
10.89824 ng/mL
Standard Deviation 16.85818
|
2.376012 ng/mL
Standard Deviation 2.273879
|
|
Stress Hormone Levels
Post-Bypass Epinephrine
|
21.9075 ng/mL
Standard Deviation 15.02187
|
20.5294 ng/mL
Standard Deviation 17.2838
|
18.176 ng/mL
Standard Deviation 22.04968
|
|
Stress Hormone Levels
End-of-Surgery Epinephrine
|
8.620669 ng/mL
Standard Deviation 6.799042
|
8.083004 ng/mL
Standard Deviation 8.808354
|
14.65742 ng/mL
Standard Deviation 18.34983
|
|
Stress Hormone Levels
24 hour Post-Surgery Epinephrine
|
3.537063 ng/mL
Standard Deviation 2.466451
|
4.418208 ng/mL
Standard Deviation 6.764226
|
5.004787 ng/mL
Standard Deviation 6.666509
|
|
Stress Hormone Levels
Baseline Cortisol
|
449.1974 ng/mL
Standard Deviation 279.4671
|
352.4913 ng/mL
Standard Deviation 265.2216
|
334.7762 ng/mL
Standard Deviation 314.6592
|
|
Stress Hormone Levels
Post-Sternotomy Cortisol
|
363.5948 ng/mL
Standard Deviation 164.9006
|
361.0074 ng/mL
Standard Deviation 223.3172
|
353.5396 ng/mL
Standard Deviation 281.4853
|
|
Stress Hormone Levels
Post-Bypass Cortisol
|
395.1298 ng/mL
Standard Deviation 173.3926
|
354.8089 ng/mL
Standard Deviation 210.7565
|
279.0063 ng/mL
Standard Deviation 188.1155
|
|
Stress Hormone Levels
End-of-Surgery Cortisol
|
463.3857 ng/mL
Standard Deviation 251.6977
|
387.3673 ng/mL
Standard Deviation 191.7376
|
333.0644 ng/mL
Standard Deviation 294.8148
|
|
Stress Hormone Levels
24 hour Post-Surgery Cortisol
|
266.8754 ng/mL
Standard Deviation 239.2913
|
265.7373 ng/mL
Standard Deviation 291.3256
|
237.5506 ng/mL
Standard Deviation 243.8181
|
SECONDARY outcome
Timeframe: 1-4 yrs post-surgeryPopulation: Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.
The Stanford-Binet Intelligence Scale is now in its fifth edition (SB5) and was released in 2003. It is a cognitive ability and intelligence test that is used to diagnose developmental or intellectual deficiencies in young children. The test measures five weighted factors and consists of both verbal and nonverbal subtests. The five factors being tested are knowledge, quantitative reasoning, visual-spatial processing, working memory, and fluid reasoning. Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150). Higher scores suggest a higher level of functioning related to each category.
Outcome measures
| Measure |
Fentanyl (Low Dose)
n=9 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=7 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=5 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
Stanford-Binet Cognitive Ability
Quantative Reasoning Score
|
96 units on a scale
Standard Deviation 18
|
82 units on a scale
Standard Deviation 15
|
106 units on a scale
Standard Deviation 22
|
|
Stanford-Binet Cognitive Ability
Knowledge Score
|
97 units on a scale
Standard Deviation 10
|
95 units on a scale
Standard Deviation 12
|
91 units on a scale
Standard Deviation 27
|
|
Stanford-Binet Cognitive Ability
Visual Spatial Processing Score
|
97 units on a scale
Standard Deviation 16
|
92 units on a scale
Standard Deviation 7
|
91 units on a scale
Standard Deviation 17
|
|
Stanford-Binet Cognitive Ability
Working Memory Score
|
92 units on a scale
Standard Deviation 10
|
84 units on a scale
Standard Deviation 13
|
94 units on a scale
Standard Deviation 17
|
|
Stanford-Binet Cognitive Ability
Fluid Reasoning Score
|
93 units on a scale
Standard Deviation 19
|
75 units on a scale
Standard Deviation 10
|
86 units on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 1-4 yrs post-surgeryPopulation: Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.
The ABAS-II is designed to evaluate whether an individual displays various functional skills necessary for daily living without the assistance of others. Thus, this instrument focuses on independent behaviors and measures what an individual actually does, in addition to measuring what he or she may be able to do. In addition, the ABAS-II focuses on behaviors an individual displays on his or her own, without assistance from others. The Parent/Primary Caregiver Form is a comprehensive, diagnostic measure of the adaptive skills that have primary relevance for the functioning of infants, toddlers, and preschoolers in the home and other settings, and can be completed by parents or other primary care providers. Each composite or domain score is determined by summing the appropriate scaled scores and then determining its equivalent composite or domain score by looking it up in a table located in the manual.The range for all scores is 50-150, with a higher score equaling a better outcome.
Outcome measures
| Measure |
Fentanyl (Low Dose)
n=9 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=7 Participants
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose) in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
Fentanyl (High Dose)
n=5 Participants
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
|---|---|---|---|
|
ABAS-II
ABAS-II Conceptual Adaptive Domain Score
|
106 units on a scale
Standard Deviation 16
|
99 units on a scale
Standard Deviation 13
|
99 units on a scale
Standard Deviation 21
|
|
ABAS-II
ABAS-II Social Adaptive Domain Score
|
106 units on a scale
Standard Deviation 8
|
105 units on a scale
Standard Deviation 13
|
102 units on a scale
Standard Deviation 24
|
|
ABAS-II
ABAS-II Practical Adaptive Domain Score
|
96 units on a scale
Standard Deviation 14
|
95 units on a scale
Standard Deviation 11
|
93 units on a scale
Standard Deviation 15
|
|
ABAS-II
ABAS-II General Adaptive Composite Score
|
102 units on a scale
Standard Deviation 13
|
100 units on a scale
Standard Deviation 13
|
96 units on a scale
Standard Deviation 21
|
Adverse Events
Fentanyl (High Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl (Low Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl (Low Dose) + Dexmedetomidine
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl (High Dose)
n=17 participants at risk
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
Fentanyl (Low Dose)
n=16 participants at risk
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=18 participants at risk
patients in this group will receive a total of 10mcg/kg of fentanyl in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr.in addition this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
|---|---|---|---|
|
Surgical and medical procedures
Morbidity
|
0.00%
0/17 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
0.00%
0/16 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
11.1%
2/18 • Number of events 2 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
Other adverse events
| Measure |
Fentanyl (High Dose)
n=17 participants at risk
patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.
Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
|
Fentanyl (Low Dose)
n=16 participants at risk
patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision
Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.
|
Fentanyl (Low Dose) + Dexmedetomidine
n=18 participants at risk
patients in this group will receive a total of 10mcg/kg of fentanyl in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Fentanyl (Low Dose) + Dexmedetomidine: Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr.in addition this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
|
|---|---|---|---|
|
Surgical and medical procedures
Unblinded
|
0.00%
0/17 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
0.00%
0/16 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place