Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
| Registry | NCT03262090 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 389 (Actual) |
| Sponsor | Guangzhou Women and Children's Medical Center (Other) |
| Conditions | Ambulatory Surgical Procedures |
| Interventions | 0.2ug/kg dexmedetomidine, 0.4ug/kg dexmedetomidine, 0.6ug/kg dexmedetomidine, 0.8ug/kg dexmedetomidine, 1.0ug/kg dexmedetomidine (Drug) |
| Dates | start 2017-09-18, primary completion 2019-05-15, completion 2019-05-21, first posted 2017-08-25, last updated 2019-06-25 |
| Locations | 1 site in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| control group | No intervention | Subjects were randomly assigned to receive saline before skin incision | |
| 0.2ug/kg dexmedetomidine | Active comparator | Drug: 0.2ug/kg dexmedetomidine | Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision |
| 0.4ug/kg dexmedetomidine | Active comparator | Drug: 0.4ug/kg dexmedetomidine | Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision |
| 0.6ug/kg dexmedetomidine | Active comparator | Drug: 0.6ug/kg dexmedetomidine | Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision |
| 0.8ug/kg dexmedetomidine | Active comparator | Drug: 0.8ug/kg dexmedetomidine | Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision |
| 1.0ug/kg dexmedetomidine | Active comparator | Drug: 1.0ug/kg dexmedetomidine | Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision |
Sex: All, ages: 4 Months to 15 Years
Inclusion Criteria: 1. patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery 2. Patients who are American Society of Anesthesiologists classification I and II 3. Patients who are 4 months through 15 years of age 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Guangzhou Women and Children Medical Center | Guangzhou, Guangdong | China |