Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery

Guangzhou Women and Children's Medical Center

Status: Completed

Conditions: Ambulatory Surgical Procedures

Treatments: Drug: 1.0ug/kg dexmedetomidine; Drug: 0.4ug/kg dexmedetomidine; Drug: 0.6ug/kg dexmedetomidine; Drug: 0.2ug/kg dexmedetomidine; Drug: 0.8ug/kg dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03262090

YShe

Details and patient eligibility

About

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

Full 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.

Enrollment: 389 patients

Sex: All

Ages: 4 months to 15 years old

Volunteers: No Healthy Volunteers

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.

2. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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389 participants in 6 patient groups

control group

No Intervention group

Description:

Subjects were randomly assigned to receive saline before skin incision

0.2ug/kg dexmedetomidine

Active Comparator group

Description:

Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision

Treatment:

Drug: 0.2ug/kg dexmedetomidine

0.4ug/kg dexmedetomidine

Active Comparator group

Description:

Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision

Treatment:

Drug: 0.4ug/kg dexmedetomidine

0.6ug/kg dexmedetomidine

Active Comparator group

Description:

Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision

Treatment:

Drug: 0.6ug/kg dexmedetomidine

0.8ug/kg dexmedetomidine

Active Comparator group

Description:

Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision

Treatment:

Drug: 0.8ug/kg dexmedetomidine

1.0ug/kg dexmedetomidine

Active Comparator group

Description:

Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision

Treatment:

Drug: 1.0ug/kg dexmedetomidine