Back to resultsEffect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
Primary Purpose
Ambulatory Surgical Procedures
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.2ug/kg dexmedetomidine
0.4ug/kg dexmedetomidine
0.6ug/kg dexmedetomidine
0.8ug/kg dexmedetomidine
1.0ug/kg dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Ambulatory Surgical Procedures focused on measuring Emergence Delirium, desoflurane, general anesthesia
Eligibility Criteria
Inclusion Criteria:
- 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
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.
Sites / Locations
- Guangzhou Women and Children Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
control group
0.2ug/kg dexmedetomidine
0.4ug/kg dexmedetomidine
0.6ug/kg dexmedetomidine
0.8ug/kg dexmedetomidine
1.0ug/kg dexmedetomidine
Arm Description
Subjects were randomly assigned to receive saline before skin incision
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
Outcomes
Primary Outcome Measures
incidence of emergence agitation at different time interval after emergence
emergence agitation was evaluated by five-point scale
Secondary Outcome Measures
sedation scales at different time interval after emergence
sedation was evaluated by MOAA/S scores
pain scale at different time interval after emergence
pain scale was evaluated by FLACC
incidence of emergence delirium at different time interval after emergence
emergence delirium was evaluated by five-point scale
Full Information
NCT ID
NCT03262090
First Posted
August 18, 2017
Last Updated
June 24, 2019
Sponsor
Guangzhou Women and Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03262090
Brief Title
Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
Official Title
Efficacy of Different Doses of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery With Desoflurane Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulatory Surgical Procedures
Keywords
Emergence Delirium, desoflurane, general anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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, and 3-9 years. 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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Subjects were randomly assigned to receive saline before skin incision
Arm Title
0.2ug/kg dexmedetomidine
Arm Type
Active Comparator
Arm Description
Subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
Arm Title
0.4ug/kg dexmedetomidine
Arm Type
Active Comparator
Arm Description
Subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
Arm Title
0.6ug/kg dexmedetomidine
Arm Type
Active Comparator
Arm Description
Subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
Arm Title
0.8ug/kg dexmedetomidine
Arm Type
Active Comparator
Arm Description
Subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
Arm Title
1.0ug/kg dexmedetomidine
Arm Type
Active Comparator
Arm Description
Subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Intervention Type
Drug
Intervention Name(s)
0.2ug/kg dexmedetomidine
Other Intervention Name(s)
Age
Intervention Description
subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
Intervention Type
Drug
Intervention Name(s)
0.4ug/kg dexmedetomidine
Other Intervention Name(s)
Age
Intervention Description
subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
Intervention Type
Drug
Intervention Name(s)
0.6ug/kg dexmedetomidine
Other Intervention Name(s)
Age
Intervention Description
subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
Intervention Type
Drug
Intervention Name(s)
0.8ug/kg dexmedetomidine
Other Intervention Name(s)
Age
Intervention Description
subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
Intervention Type
Drug
Intervention Name(s)
1.0ug/kg dexmedetomidine
Other Intervention Name(s)
Age
Intervention Description
subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
Primary Outcome Measure Information:
Title
incidence of emergence agitation at different time interval after emergence
Description
emergence agitation was evaluated by five-point scale
Time Frame
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Secondary Outcome Measure Information:
Title
sedation scales at different time interval after emergence
Description
sedation was evaluated by MOAA/S scores
Time Frame
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Title
pain scale at different time interval after emergence
Description
pain scale was evaluated by FLACC
Time Frame
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
Title
incidence of emergence delirium at different time interval after emergence
Description
emergence delirium was evaluated by five-point scale
Time Frame
at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 2h after emergence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia Zheng, Doctor
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Dexmedetomidine on the Prevention of Emergence Agitation in Children Undergoing Day Surgery
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