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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 51 study subjects completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 The enrollee was withdrawn from the study after signing the consent and prior to enrolling to one of the arms of the study.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Fentanyl (High Dose)   Fentanyl (Low Dose)   Fentanyl (Low Dose) + Dexmedetomidine
STARTED   17   16   18 
COMPLETED   17   16   15 
NOT COMPLETED   0   0   3 
Protocol Violation                0                0                1 
surgical complications unrelated to stud                0                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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

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 Total of all reporting groups

Baseline Measures
   Fentanyl (High Dose)   Fentanyl (Low Dose)   Fentanyl (Low Dose) + Dexmedetomidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   15   48 
Age 
[Units: Participants]
Count of 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 
[Units: Months]
Median (Full Range)
 4 
 (1 to 35) 
 4 
 (3 to 7) 
 5 
 (2 to 21) 
 4 
 (1 to 35) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   17   16   15   48 


  Outcome Measures

1.  Primary:   ACTH and Cytokine Levels   [ 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. ]

2.  Primary:   Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.   [ Time Frame: Hospital admission to discharge from CTICU (average of 2-4 days) ]

3.  Primary:   Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.   [ Time Frame: Time of intubation to extubation (variable) ]

4.  Primary:   Stanford-Binet Intelligence Scales   [ Time Frame: 1-4 yrs. post-surgery ]

5.  Primary:   Stress Hormone Levels   [ 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. ]

6.  Secondary:   Stanford-Binet Cognitive Ability   [ Time Frame: 1-4 yrs post-surgery ]

7.  Secondary:   ABAS-II   [ Time Frame: 1-4 yrs post-surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: Aymen.Naguib@nationwidechildrens.org


Publications:

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