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

N/ACompletedNCT03262090

Guangzhou Women and Children's Medical Center389 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

389

Conditions

Ambulatory Surgical Procedures

Interventions

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

0.4ug/kg dexmedetomidineDRUG

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

0.6ug/kg dexmedetomidineDRUG

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

0.8ug/kg dexmedetomidineDRUG

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

1.0ug/kg dexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

incidence of emergence agitation at different time interval after emergence

emergence agitation was evaluated by five-point scale

Time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

Secondary Outcomes

sedation scales at different time interval after emergence

sedation was evaluated by MOAA/S scores

Time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

pain scale at different time interval after emergence

pain scale was evaluated by FLACC

Time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

incidence of emergence delirium at different time interval after emergence

emergence delirium was evaluated by five-point scale

Time frame: at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence

Data from ClinicalTrials.gov

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