Clinical trial NCT03262090: Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
Official title: Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgical Procedures
Keywords: Emergence Delirium
desoflurane
general anesthesia
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 389
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of emergence agitation at different time interval after emergence
timeFrame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary outcomes:
measure: sedation scales at different time interval after emergence
timeFrame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
measure: pain scale at different time interval after emergence
timeFrame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
measure: incidence of emergence delirium at different time interval after emergence
timeFrame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Xia Zheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: