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

Ambulatory Surgical Procedures Clinical Trial

Official title:

Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262090
• Other study ID #: YShe
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: May 21, 2019

Study information

• Verified date: June 2019
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: May 21, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Emergence Delirium

Intervention

Drug:
• 0.2ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
• 0.4ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
• 0.6ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
• 0.8ug/kg dexmedetomidine
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
• 1.0ug/kg dexmedetomidine
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision

Locations

Country	Name	City	State
China	Guangzhou Women and Children Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of emergence agitation at different time interval after emergence	emergence agitation was evaluated by five-point scale	at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary	sedation scales at different time interval after emergence	sedation was evaluated by MOAA/S scores	at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary	pain scale at different time interval after emergence	pain scale was evaluated by FLACC	at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary	incidence of emergence delirium at different time interval after emergence	emergence delirium was evaluated by five-point scale	at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence