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
1 other identifier
interventional
389
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2019
CompletedJune 25, 2019
June 1, 2019
1.7 years
August 18, 2017
June 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
sedation scales at different time interval after emergence
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
pain scale at different time interval after emergence
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
incidence of emergence delirium at different time interval after emergence
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Study Arms (6)
control group
NO INTERVENTIONSubjects were randomly assigned to receive saline before skin incision
0.2ug/kg dexmedetomidine
ACTIVE COMPARATORSubjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
0.4ug/kg dexmedetomidine
ACTIVE COMPARATORSubjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
0.6ug/kg dexmedetomidine
ACTIVE COMPARATORSubjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
0.8ug/kg dexmedetomidine
ACTIVE COMPARATORSubjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
1.0ug/kg dexmedetomidine
ACTIVE COMPARATORSubjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Interventions
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Eligibility Criteria
You may qualify if:
- patients who undergo elective unilateral inguinal hernia or hydrocele testis day surgery
- Patients who are American Society of Anesthesiologists classification I and II
- Patients who are 4 months through 15 years of age
You may not qualify if:
- \. children with history of respiratory tract infection 1 week preoperatively. 2. patients with preoperative liver and/or kidney dysfunction, or with mental abnormalities.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xia Zheng, Doctor
Guangzhou Women and Children's Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
August 18, 2017
First Posted
August 25, 2017
Study Start
September 18, 2017
Primary Completion
May 15, 2019
Study Completion
May 21, 2019
Last Updated
June 25, 2019
Record last verified: 2019-06