Trial Outcomes & Findings for The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease (NCT NCT00480740)
NCT ID: NCT00480740
Last Updated: 2015-06-26
Results Overview
Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values. Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Up to 24 hours following cardiac catheterization
Results posted on
2015-06-26
Participant Flow
Patients were recruited from cardiology outpatient clinic. The study is anticipating to enroll 104 patients.
74 subjects assessed for eligibility, 9 were excluded; 12 did not meet inclusion criteria; 12 refused to enroll; resulting in 41 subjects enrolled
Participant milestones
| Measure |
Normal Physiology
diagnostic cardiac catheterization in children with normal cardiac physiology
|
Cardiac Transplant
diagnostic cardiac catheterization in children with a transplanted heart
|
Fontan Physiology
diagnostic cardiac catheterization in children with a transplanted ventricle
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
9
|
6
|
|
Overall Study
COMPLETED
|
26
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
Baseline characteristics by cohort
| Measure |
Normal Physiology
n=26 Participants
|
Cardiac Transplant
n=9 Participants
|
Fontan Physiology
n=6 Participants
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4.3 years
STANDARD_DEVIATION 4 • n=5 Participants
|
11 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
5.5 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Weight (kg)
|
19.1 kg
STANDARD_DEVIATION 14.3 • n=5 Participants
|
35.2 kg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
21.4 kg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
27.3 kg
STANDARD_DEVIATION 13.6 • n=4 Participants
|
|
American Society of Anesthesiology (ASA) physical status classification
ASA 1
|
18 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
American Society of Anesthesiology (ASA) physical status classification
ASA 2
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
American Society of Anesthesiology (ASA) physical status classification
ASA 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Primary diagnosis
ASD
|
10 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Primary diagnosis
PDA
|
16 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Primary diagnosis
PA with IVS
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Primary diagnosis
HLHS
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Primary diagnosis
Unbalanced AVC
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Primary diagnosis
Cardiomyopathy
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Primary diagnosis
Tricuspid Atresia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Primary diagnosis
DORV
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Primary diagnosis
Ebstein's anomaly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours following cardiac catheterizationNon-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values. Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.
Outcome measures
| Measure |
Normal Physiology
n=26 Participants
diagnostic cardiac catheterization in children with normal cardiac physiology
|
Cardiac Transplant
n=9 Participants
diagnostic cardiac catheterization in children with a transplanted heart
|
Fontan Physiology
n=6 Participants
diagnostic cardiac catheterization in children with a transplanted ventricle
|
|---|---|---|---|
|
Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Heart Rate
|
-0.14 percentage of change from baseline
Interval -0.15 to -0.13
|
-0.16 percentage of change from baseline
Interval -0.2 to -0.12
|
-0.21 percentage of change from baseline
Interval -0.22 to -0.2
|
|
Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Systolic Pressure
|
0.15 percentage of change from baseline
Interval 0.07 to 0.23
|
0.18 percentage of change from baseline
Interval 0.08 to 0.28
|
0.22 percentage of change from baseline
Interval 0.16 to 0.28
|
|
Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Diastolic Pressure
|
0.23 percentage of change from baseline
Interval 0.13 to 0.36
|
0.19 percentage of change from baseline
Interval 0.13 to 0.25
|
0.09 percentage of change from baseline
Interval -0.11 to 0.29
|
|
Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Mean Pressure
|
0.23 percentage of change from baseline
Interval 0.17 to 0.29
|
0.16 percentage of change from baseline
Interval 0.03 to 0.29
|
0.08 percentage of change from baseline
Interval -0.09 to 0.25
|
|
Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Bispectral Index
|
0.04 percentage of change from baseline
Interval -0.03 to 0.11
|
0.16 percentage of change from baseline
Interval -0.11 to 0.43
|
-0.14 percentage of change from baseline
Interval -0.42 to 0.13
|
Adverse Events
Cardiac Transplant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fontan Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Physiology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place