NCT03262090

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 4 Months – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ambulatory Surgical Procedures

Interventions

Type	Name	Description
DRUG	0.2ug/kg dexmedetomidine	subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
DRUG	0.4ug/kg dexmedetomidine	subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
DRUG	0.6ug/kg dexmedetomidine	subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
DRUG	0.8ug/kg dexmedetomidine	subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
DRUG	1.0ug/kg dexmedetomidine	subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision

Timeline

• Start date: 2017-09-18
• Primary completion: 2019-05-15
• Completion: 2019-05-21
• First posted: 2017-08-25
• Last updated: 2019-06-25

Locations

1 site across 1 country: China