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Measures to Lower the Stress Response in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00848393
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Tetralogy of Fallot (TOF)
Ventricular Septal Defects (VSD)
Atrioventricular Septal Defects (AVSD)
Interventions Drug: Fentanyl (High Dose)
Drug: Fentanyl (Low Dose)
Drug: Fentanyl (Low Dose) + Dexmedetomidine
Enrollment 52
Recruitment Details A total of 51 study subjects completed the study.
Pre-assignment Details 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 The enrollee was withdrawn from the study after signing the consent and prior to enrolling to one of the arms of the study.
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 17 16 18
Completed 17 16 15
Not Completed 0 0 3
Reason Not Completed
Protocol Violation             0             0             1
surgical complications unrelated to stud             0             0             2
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 17 16 15 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 15 participants 48 participants
<=18 years
17
 100.0%
16
 100.0%
15
 100.0%
48
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 17 participants 16 participants 15 participants 48 participants
4
(1 to 35)
4
(3 to 7)
5
(2 to 21)
4
(1 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 15 participants 48 participants
Female
8
  47.1%
4
  25.0%
4
  26.7%
16
  33.3%
Male
9
  52.9%
12
  75.0%
11
  73.3%
32
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 15 participants 48 participants
17 16 15 48
1.Primary Outcome
Title ACTH and Cytokine Levels
Hide Description 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.
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline ACTH (pg/mL) 116.9  (117.0) 182.7  (111.3) 135.3  (129.8)
Post-Sternotomy ACTH (pg/mL) 44.5  (39.7) 86.2  (76.5) 106.9  (153.5)
Post-Bypass ACTH (pg/mL) 57.2  (61.2) 172.7  (121.8) 191.6  (220.2)
End-Of-Surgery ACTH (pg/mL) 66.4  (77.9) 155.0  (107.5) 154.1  (166.6)
24 hour Post-Surgery ACTH (pg/mL) 12.7  (7.4) 53.2  (24.3) 22.4  (130.3)
Baseline TNF-alpha (pg/mL) 15.70077  (16.401) 25.294  (31.22396) 8.018182  (10.68364)
Post-Sternotomy TNF-alpha (pg/mL) 26.51846  (33.64902) 24.497  (33.8474) 17.88636  (16.96651)
Post-Bypass TNF-alpha (pg/mL) 24.30615  (23.03753) 25.787  (29.267) 20.34364  (14.03041)
End-Of-Surgery TNF-alpha (pg/mL) 23.87077  (17.18903) 24.857  (18.82328) 23.06091  (18.8737)
24 hour Post-Surgery TNF-alpha (pg/mL) 15.79  (30.8563) 11.954  (17.23623) 21.13909  (19.00043)
Baseline IL-6 (pg/mL) 6.637058824  (4.356124661) 4.757142857  (2.178819118) 5.542857143  (3.455366904)
Post-Sternotomy IL-6 (pg/mL) 5.402353  (3.623996) 12.17333  (28.79942) 6.241333  (4.0798)
Post-Bypass IL-6 (pg/mL) 5.098824  (3.10355) 5.509375  (3.93354) 5.040667  (2.583747)
End-Of-Surgery IL-6 (pg/mL) 20.48571  (11.00962) 22.47333  (12.59657) 20.79231  (12.55537)
24 hour Post-Surgery IL-6 (pg/mL) 126.0813  (141.7456) 117.975  (95.86805) 142.1571  (129.4279)
Baseline IL-8 (pg/mL) 17.12353  (24.88048) 10.44286  (1.839195) 10.25714  (1.336306)
Post-Sternotomy IL-8 (pg/mL) 20.77647  (42.23163) 10.66667  (2.941736) 10.86667  (1.980861)
Post-Bypass IL-8 (pg/mL) 9.770588  (2.389499) 10.13125  (2.15769) 9.673333  (1.182894)
End-Of-Surgery IL-8 (pg/mL) 28.1  (17.28596) 33.12667  (25.1446) 37.22143  (43.66227)
24 hour Post-Surgery IL-8 (pg/mL) 49.07143  (69.39429) 47.25  (99.4908) 24.27143  (14.72541)
Baseline IL-10 (pg/mL) 10.82353  (1.952412) 9.9  (0.00000) 12.76429  (9.373252)
Post-Sternotomy IL-10 (pg/mL) 9.911765  (2.749291) 9.9  (0.00000) 14.10667  (13.63863)
Post-Bypass IL-10 (pg/mL) 9.488235  (1.872793) 9.9  (2.581989) 12.30667  (10.78136)
End-Of-Surgery IL-10 (pg/mL) 345.4412  (445.7443) 325.55  (262.3603) 569.2714  (858.2538)
24 hour Post-Surgery IL-10 (pg/mL) 10.80667  (1.907304) 14.80833  (10.65888) 9.692857  (0.775058)
2.Primary Outcome
Title Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.
Hide Description [Not Specified]
Time Frame Hospital admission to discharge from CTICU (average of 2-4 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 17 16 15
Median (Full Range)
Unit of Measure: Days
1
(1 to 8)
1
(1 to 4)
2
(1 to 5)
3.Primary Outcome
Title Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.
Hide Description [Not Specified]
Time Frame Time of intubation to extubation (variable)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 17 16 15
Median (Full Range)
Unit of Measure: Hours
10.75
(0 to 27.32)
3.79
(0 to 16)
2.4
(0 to 2.4)
4.Primary Outcome
Title Stanford-Binet Intelligence Scales
Hide Description 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).
Time Frame 1-4 yrs. post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 5 9 7
Mean (Standard Deviation)
Unit of Measure: IQ
Nonverbal IQ composite score 92  (19) 98  (15) 89  (6)
Verbal IQ composite score 93  (26) 91  (17) 80  (8)
Full-scale IQ composite score 93  (24) 94  (15) 83  (5)
5.Primary Outcome
Title Stress Hormone Levels
Hide Description Cortisol, epinephrine, and norepinephrine assayed by enzyme-linked immunosorbent assay (ELISA).
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

This arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. First half-dose given at induction and second half-dose given before incision.

Fentanyl (High Dose): Fentanyl (High Dose) 25 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.

This arm will receive a total of 10 mcg/kg of Fentanyl (Low Dose). First half-dose will be given at induction and second half -dose given before incision.

Fentanyl (Low Dose): Fentanyl (Low Dose) 10 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.

This arm will receive10 mcg/kg of Fentanyl (Low Dose) -2 divided doses. Dexmedetomidine (Dex) loading dose-1 mcg/kg over 10 min, then Dex infusion at 0.5mcg/kg/hr.

Fentanyl (Low Dose) + Dexmedetomidine: 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.

Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Norepinephrine 13.32618  (10.1541) 19.34153  (9.880667) 19.45968  (13.08422)
Post-Sternotomy Norepinephrine 16.2606  (9.929948) 17.08766  (8.419782) 12.74458  (11.4669)
Post-Bypass Norepinephrine 23.35796  (13.54953) 22.31064  (17.06955) 19.73612  (17.07041)
End-of-Surgery Norepinephrine 11.22376  (8.599634) 10.74731  (8.144776) 7.727055  (13.04373)
24 hour Post-Surgery Norepinephrine 19.03031  (17.41692) 20.85433  (18.38192) 26.67379  (26.06332)
Baseline ephinephrine 2.7848  (3.127335) 6.439221  (7.528216) 5.876335  (9.551871)
Post-Sternotomy Epinephrine 2.376012  (2.273879) 9.843591  (8.670264) 10.89824  (16.85818)
Post-Bypass Epinephrine 18.176  (22.04968) 21.9075  (15.02187) 20.5294  (17.2838)
End-of-Surgery Epinephrine 14.65742  (18.34983) 8.620669  (6.799042) 8.083004  (8.808354)
24 hour Post-Surgery Epinephrine 5.004787  (6.666509) 3.537063  (2.466451) 4.418208  (6.764226)
Baseline Cortisol 334.7762  (314.6592) 449.1974  (279.4671) 352.4913  (265.2216)
Post-Sternotomy Cortisol 353.5396  (281.4853) 363.5948  (164.9006) 361.0074  (223.3172)
Post-Bypass Cortisol 279.0063  (188.1155) 395.1298  (173.3926) 354.8089  (210.7565)
End-of-Surgery Cortisol 333.0644  (294.8148) 463.3857  (251.6977) 387.3673  (191.7376)
24 hour Post-Surgery Cortisol 237.5506  (243.8181) 266.8754  (239.2913) 265.7373  (291.3256)
6.Secondary Outcome
Title Stanford-Binet Cognitive Ability
Hide Description 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.
Time Frame 1-4 yrs post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 5 9 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Quantative Reasoning Score 106  (22) 96  (18) 82  (15)
Knowledge Score 91  (27) 97  (10) 95  (12)
Visual Spatial Processing Score 91  (17) 97  (16) 92  (7)
Working Memory Score 94  (17) 92  (10) 84  (13)
Fluid Reasoning Score 86  (20) 93  (19) 75  (10)
7.Secondary Outcome
Title ABAS-II
Hide Description 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.
Time Frame 1-4 yrs post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 5 9 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
ABAS-II General Adaptive Composite Score 96  (21) 102  (13) 100  (13)
ABAS-II Conceptual Adaptive Domain Score 99  (21) 106  (16) 99  (13)
ABAS-II Social Adaptive Domain Score 102  (24) 106  (8) 105  (13)
ABAS-II Practical Adaptive Domain Score 93  (15) 96  (14) 95  (11)
Time Frame Adverse event data were collected for each patient from start of surgical procedure until hospital discharge (Length of Hospital Stay averaging 5 Days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
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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.

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.

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.

All-Cause Mortality
Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/16 (0.00%)      2/18 (11.11%)    
Surgical and medical procedures       
Morbidity   0/17 (0.00%)  0 0/16 (0.00%)  0 2/18 (11.11%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl (High Dose) Fentanyl (Low Dose) Fentanyl (Low Dose) + Dexmedetomidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/16 (0.00%)      1/18 (5.56%)    
Surgical and medical procedures       
Unblinded   0/17 (0.00%)  0 0/16 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
Small sample size related to: study components conceived after completion of initial stress response study, declined participation, and loss to follow-up. Inability to obtain pre-surgical baseline neurodevelopmental evaluations.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Aymen Naguib, MD
Organization: Nationwide Children's Hospital
Phone: 6147220596
Responsible Party: Aymen N Naguib, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00848393     History of Changes
Other Study ID Numbers: IRB08-00029
101911 ( Other Identifier: FDA )
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: January 26, 2016
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018