Trial Outcomes & Findings for The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders (NCT NCT03799783)
NCT ID: NCT03799783
Last Updated: 2021-02-02
Results Overview
the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.
COMPLETED
PHASE2
19 participants
10 minutes
2021-02-02
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
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|---|---|
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Overall Study
STARTED
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19
|
|
Overall Study
COMPLETED
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19
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
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|---|---|
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Age, Continuous
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7.3 years
STANDARD_DEVIATION 4 • n=19 Participants
|
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Sex: Female, Male
Female
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10 Participants
n=19 Participants
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Sex: Female, Male
Male
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9 Participants
n=19 Participants
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PRIMARY outcome
Timeframe: 10 minutesthe PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.
Outcome measures
| Measure |
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
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|---|---|
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Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)
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13 Participants
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SECONDARY outcome
Timeframe: during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)any adverse event potentially related with DEX-administration
Outcome measures
| Measure |
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
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|---|---|
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Number of Patients With Adverse Events
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10 Participants
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Adverse Events
Dexmedetomidine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine
n=19 participants at risk
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
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|---|---|
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Cardiac disorders
hypotension
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31.6%
6/19 • Number of events 6 • 90 minutes
Other (not including serious) adverse events
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Cardiac disorders
bradycardia
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21.1%
4/19 • Number of events 4 • 90 minutes
Other (not including serious) adverse events
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place