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Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.
About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-6 months (Group 1) | Active Comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
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| 7-12 months (Group 2) | Active Comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
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| 13-24 months (Group 3) | Active Comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
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| 25-36 months (Group 4) | Active Comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal dexmedetomidine | Drug | Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation. The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg. |
| Measure | Description | Time Frame |
|---|---|---|
| The median effect dose of intranasal dexmedetomidine | Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3 | up to 1 hours after MRI scaning |
| Measure | Description | Time Frame |
|---|---|---|
| sedation induction time | Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation 0 Does not respond to a noxious stimulus
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| Measure | Description | Time Frame |
|---|---|---|
| heart rate | changes in heart rates at the baseline, before and 15 , 60, 75, 90 min after rescue drug administration | baseline, before and 15 , 60, 75, 90 min after rescue drug administration |
| non-invasive systolic blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology of Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27627818 | Derived | Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353. |
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| up to 30 min after rescue drug administration |
| Wake -up time | Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke | up to 4 hours after rescue drug administration |
changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
| baseline, before and 15 , 60, 75, 90 min after rescue drug administration |
| Oxyhemoglobin desaturation | Significant Oxyhemoglobin desaturation was defined as<94% | baseline and four hours after rescue medicine administration |