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Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. In infants, there is a high incidence of emergence agitation (EA) after desoflurane anesthesia. The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia
subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years group, and 3-12 years group. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0, 0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Subjects were randomly assigned to receive saline before skin incision | |
| 0.2ug/kg dexmedetomidine | Active Comparator | Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision |
|
| 0.4ug/kg dexmedetomidine | Active Comparator | Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision |
|
| 0.6ug/kg dexmedetomidine | Active Comparator | Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision |
|
| 0.8ug/kg dexmedetomidine | Active Comparator | Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision |
|
| 1.0ug/kg dexmedetomidine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.2ug/kg dexmedetomidine | Drug | subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of emergence agitation at different time interval after emergence | emergence agitation was evaluated by five-point scale | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence |
| Measure | Description | Time Frame |
|---|---|---|
| sedation scales at different time interval after emergence | sedation was evaluated by MOAA/S scores | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence |
| pain scale at different time interval after emergence |
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Inclusion Criteria:
Exclusion Criteria:
1. children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities.
3. patients with any congenital malformation or acquired disease that could increase the risks of anesthesia and the dose of anesthetics (such as, but not limited to, congenital heart disease, hydronephrosis, nutrition dysplasia). 4. patients with long-term use of sedative or analgesic drugs.
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| Name | Affiliation | Role |
|---|---|---|
| Xia Zheng, Doctor | Guangzhou Women and Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children Medical Center | Guangzhou | Guangdong | 510000 | China |
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The aim of the present preliminary study was to determine the safety and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia. Subjects who underwent day surgery were stratified into two age groups as follows: low to 3 years, and 3-9 years. Then they were randomly assigned to receive one of six doses of intravenous dexmedetomidine: 0,0.2, 0.4, 0.6, 0.8 ,1.0ug/kg before skin incision.
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Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision |
|
| 0.4ug/kg dexmedetomidine | Drug | subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision |
|
|
| 0.6ug/kg dexmedetomidine | Drug | subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision |
|
|
| 0.8ug/kg dexmedetomidine | Drug | subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision |
|
|
| 1.0ug/kg dexmedetomidine | Drug | subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision |
|
|
pain scale was evaluated by FLACC
| at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence |
| incidence of emergence delirium at different time interval after emergence | emergence delirium was evaluated by five-point scale | at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000375 | Aging |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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