Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- 0.4ug/kg dexmedetomidine
- Conditions
- Ambulatory Surgical Procedures
- Sponsor
- Guangzhou Women and Children's Medical Center
- Enrollment
- 389
- Locations
- 1
- Primary Endpoint
- incidence of emergence agitation at different time interval after emergence
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Ying Jun She, MD
Dr.
Guangzhou Women and Children's Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •children with history of respiratory tract infection 1 week preoperatively.
- •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).
- •patients with long-term use of sedative or analgesic drugs.
Arms & Interventions
0.4ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
Intervention: 0.4ug/kg dexmedetomidine
0.6ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
Intervention: 0.6ug/kg dexmedetomidine
0.2ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
Intervention: 0.2ug/kg dexmedetomidine
0.8ug/kg dexmedetomidine
Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
Intervention: 0.8ug/kg dexmedetomidine
1.0ug/kg dexmedetomidine
Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Intervention: 1.0ug/kg dexmedetomidine
Outcomes
Primary Outcomes
incidence of emergence agitation at different time interval after emergence
Time Frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
emergence agitation was evaluated by five-point scale
Secondary Outcomes
- sedation scales at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)
- incidence of emergence delirium at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)
- pain scale at different time interval after emergence(at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence)