Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
- Conditions
- Ambulatory Surgical Procedures
- Interventions
- Registration Number
- NCT03262090
- Lead Sponsor
- Guangzhou Women and Children's Medical Center
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
- patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery
- Patients who are American Society of Anesthesiologists classification I and II
- Patients who are 4 months through 15 years of age
-
children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.4ug/kg dexmedetomidine 0.4ug/kg dexmedetomidine Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision 0.6ug/kg dexmedetomidine 0.6ug/kg dexmedetomidine Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision 0.8ug/kg dexmedetomidine 0.8ug/kg dexmedetomidine Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision 0.2ug/kg dexmedetomidine 0.2ug/kg dexmedetomidine Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision 1.0ug/kg dexmedetomidine 1.0ug/kg dexmedetomidine Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
- Primary Outcome Measures
Name Time Method incidence of emergence agitation at different time interval after emergence at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence emergence agitation was evaluated by five-point scale
- Secondary Outcome Measures
Name Time Method sedation scales at different time interval after emergence at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence sedation was evaluated by MOAA/S scores
incidence of emergence delirium at different time interval after emergence at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence emergence delirium was evaluated by five-point scale
pain scale at different time interval after emergence at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence pain scale was evaluated by FLACC
Trial Locations
- Locations (1)
Guangzhou Women and Children Medical Center
🇨🇳Guangzhou, Guangdong, China
Guangzhou Women and Children Medical Center🇨🇳Guangzhou, Guangdong, China