Ambulatory Surgical Procedures
Conditions
Keywords
Emergence Delirium, desoflurane, general anesthesia
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.
Interventions
DRUG0.2ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
DRUG0.4ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
DRUG0.6ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
DRUG0.8ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
DRUG1.0ug/kg dexmedetomidine
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Months to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed