Trial Outcomes & Findings for The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children (NCT NCT02353169)
NCT ID: NCT02353169
Last Updated: 2019-10-07
Results Overview
Absolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
60 seconds post-intervention
Results posted on
2019-10-07
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine 0.25mcg/kg
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
16
|
15
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
4
|
3
|
Reasons for withdrawal
| Measure |
Dexmedetomidine 0.25mcg/kg
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
|---|---|---|---|---|
|
Overall Study
QTc > 450 msec
|
1
|
1
|
1
|
1
|
|
Overall Study
OR team declined
|
2
|
0
|
0
|
0
|
|
Overall Study
Inhalational induction
|
0
|
2
|
0
|
0
|
|
Overall Study
ECG data error
|
0
|
3
|
2
|
2
|
|
Overall Study
Pre-op medication
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine 0.25mcg/kg
n=12 Participants
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
n=12 Participants
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
n=12 Participants
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
n=12 Participants
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
48 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=48 Participants
|
|
Age, Continuous
|
4.5 years
n=12 Participants
|
4.5 years
n=12 Participants
|
5 years
n=12 Participants
|
4.5 years
n=12 Participants
|
5 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
19 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
29 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
48 participants
n=48 Participants
|
|
Heart Rate (beats/min)
|
88.9 beats/min
STANDARD_DEVIATION 17.8 • n=12 Participants
|
85.7 beats/min
STANDARD_DEVIATION 13.4 • n=12 Participants
|
84.6 beats/min
STANDARD_DEVIATION 12.2 • n=12 Participants
|
80.7 beats/min
STANDARD_DEVIATION 12.5 • n=12 Participants
|
85.0 beats/min
STANDARD_DEVIATION 14.0 • n=48 Participants
|
|
Corrected QT interval (ms)
|
404.9 ms
STANDARD_DEVIATION 17.1 • n=12 Participants
|
408.8 ms
STANDARD_DEVIATION 15.2 • n=12 Participants
|
409.5 ms
STANDARD_DEVIATION 17.2 • n=12 Participants
|
404.0 ms
STANDARD_DEVIATION 24.1 • n=12 Participants
|
406.8 ms
STANDARD_DEVIATION 18.2 • n=48 Participants
|
|
Interval between the peak and the end of the ECG T wave (Tp-e)
|
66.7 ms
STANDARD_DEVIATION 7.2 • n=12 Participants
|
63.0 ms
STANDARD_DEVIATION 9.4 • n=12 Participants
|
62.8 ms
STANDARD_DEVIATION 6.1 • n=12 Participants
|
65.3 ms
STANDARD_DEVIATION 5.2 • n=12 Participants
|
64.4 ms
STANDARD_DEVIATION 7.1 • n=48 Participants
|
PRIMARY outcome
Timeframe: 60 seconds post-interventionAbsolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.
Outcome measures
| Measure |
Dexmedetomidine 0.25mcg/kg
n=12 Participants
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
n=12 Participants
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
n=12 Participants
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
n=12 Participants
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
|---|---|---|---|---|
|
Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention
Tp-e Post-intervention
|
67.8 ms
Standard Deviation 6.0
|
64.0 ms
Standard Deviation 10.0
|
64.3 ms
Standard Deviation 6.9
|
66.3 ms
Standard Deviation 5.9
|
|
Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention
QTc Post-intervention
|
395.9 ms
Standard Deviation 16.1
|
390.2 ms
Standard Deviation 24.0
|
395.4 ms
Standard Deviation 18.7
|
416.4 ms
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: over 30 minutes post-interventionBlood glucose levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1 mL venous blood sample with blood gas analyzer.
Outcome measures
| Measure |
Dexmedetomidine 0.25mcg/kg
n=12 Participants
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
n=12 Participants
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
n=12 Participants
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
n=12 Participants
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
|---|---|---|---|---|
|
Blood Glucose Levels at 15min and 30min Post-intervention
Glucose 15 minutes after intervention
|
5.3 mmol/L
Standard Deviation 0.7
|
5.6 mmol/L
Standard Deviation 0.7
|
5.9 mmol/L
Standard Deviation 0.7
|
4.9 mmol/L
Standard Deviation 0.7
|
|
Blood Glucose Levels at 15min and 30min Post-intervention
Glucose 30 minutes after intervention
|
5.0 mmol/L
Standard Deviation 0.7
|
5.0 mmol/L
Standard Deviation 0.7
|
5.5 mmol/L
Standard Deviation 0.6
|
5.1 mmol/L
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: over 30 minutes post-interventionBlood potassium levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1mL venous blood sample with blood gas analyzer
Outcome measures
| Measure |
Dexmedetomidine 0.25mcg/kg
n=12 Participants
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.5mcg/kg
n=12 Participants
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Dexmedetomidine 0.75mcg/kg
n=12 Participants
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Dexmedetomidine
|
Saline Bolus
n=12 Participants
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
normal saline solution
|
|---|---|---|---|---|
|
Blood Potassium Levels at 15min and 30min Post-intervention
Potassium 15 minutes after intervention
|
3.8 mEq/L
Standard Deviation 0.7
|
3.7 mEq/L
Standard Deviation 0.2
|
3.8 mEq/L
Standard Deviation 0.2
|
3.9 mEq/L
Standard Deviation 0.4
|
|
Blood Potassium Levels at 15min and 30min Post-intervention
Potassium 30 minutes after intervention
|
3.6 mEq/L
Standard Deviation 0.3
|
3.6 mEq/L
Standard Deviation 0.4
|
3.8 mEq/L
Standard Deviation 0.2
|
3.8 mEq/L
Standard Deviation 0.2
|
Adverse Events
Dexmedetomidine 0.25mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine 0.5mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine 0.75mcg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Bolus
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
Simon D. Whyte
British Columbia Children's Hospital Research Institute
Phone: 604-875-2711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place