Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children
Primary Purpose
Emergence Agitation
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
saline
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Agitation
Eligibility Criteria
Inclusion Criteria:
- Age between 2-7 years old
- American Society of Anesthesiologists(ASA) score of I or II
- Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane
Exclusion Criteria:
- Emergency surgery
- were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
- had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
- intellectual disability, or neurological illness with agitation-like symptoms
- weighed more than 50 kg
- were allergic to dexmedetomidine
- The use of sedative or analgesic medications before surgery
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine group
Control Comparator group
Arm Description
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
the children received 10ml saline over 10 minutes after induction of anesthesia
Outcomes
Primary Outcome Measures
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Use the Pediatric Anesthesia Emergence Delirium (PAED) scale to record the incidence of EA.The score ranges from 0 to 20 points. A score of 10 or above is considered as EA.
Secondary Outcome Measures
Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Use the Face, Legs, Activity, Cry, Consolability (FLACC) scale to record the pain scores. The score ranges from 0 to 10 points. A score of 4 or above is considered as pain.
Rescue analgesia and sedative drug consumption
Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit
Incidence of adverse events
Incidence of adverse events in the post-anaesthesia care unit
Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale
Use the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale to record the incidence of Post-hospitalization negative behaviour changes.This consists of 27 items describing six subscales: general anxiety, separation anxiety, sleep anxiety, eating disturbances, aggression against authority and apathy/withdrawal.The possible answers were provided on a scale from 1 to 5 ('much less', 'less', 'unchanged', 'more' or 'much more' than before hospitalisation).A score of 0 was awarded if no negative behaviour was reported either before or after surgery.Total score was calculated by adding up all responses.
Full Information
NCT ID
NCT03596775
First Posted
June 20, 2018
Last Updated
September 5, 2018
Sponsor
Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03596775
Brief Title
Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children
Official Title
Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University
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 (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.
Detailed Description
The high incidence of EA and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. Dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. It provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. It also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance P release. The study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on EA in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
Arm Title
Control Comparator group
Arm Type
Placebo Comparator
Arm Description
the children received 10ml saline over 10 minutes after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.
Primary Outcome Measure Information:
Title
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Description
Use the Pediatric Anesthesia Emergence Delirium (PAED) scale to record the incidence of EA.The score ranges from 0 to 20 points. A score of 10 or above is considered as EA.
Time Frame
within 30 minutes after extubation in the post-anaesthesia care unit
Secondary Outcome Measure Information:
Title
Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Description
Use the Face, Legs, Activity, Cry, Consolability (FLACC) scale to record the pain scores. The score ranges from 0 to 10 points. A score of 4 or above is considered as pain.
Time Frame
within 30 minutes after extubation in the post-anaesthesia care unit
Title
Rescue analgesia and sedative drug consumption
Description
Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit
Time Frame
within 30 minutes after extubation in the post-anaesthesia care unit
Title
Incidence of adverse events
Description
Incidence of adverse events in the post-anaesthesia care unit
Time Frame
within 30 minutes after extubation in the post-anaesthesia care unit
Title
Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale
Description
Use the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale to record the incidence of Post-hospitalization negative behaviour changes.This consists of 27 items describing six subscales: general anxiety, separation anxiety, sleep anxiety, eating disturbances, aggression against authority and apathy/withdrawal.The possible answers were provided on a scale from 1 to 5 ('much less', 'less', 'unchanged', 'more' or 'much more' than before hospitalisation).A score of 0 was awarded if no negative behaviour was reported either before or after surgery.Total score was calculated by adding up all responses.
Time Frame
1 day, 2 days,30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 2-7 years old
American Society of Anesthesiologists(ASA) score of I or II
Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane
Exclusion Criteria:
Emergency surgery
were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
intellectual disability, or neurological illness with agitation-like symptoms
weighed more than 50 kg
were allergic to dexmedetomidine
The use of sedative or analgesic medications before surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Dong Liu, M.S
Phone
+86-13951355136
Email
liujindong1818@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Dong Liu, M.S
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data(IPD) will be available when this trial is finished and the article have been published
Citations:
PubMed Identifier
25212274
Citation
Costi D, Cyna AM, Ahmed S, Stephens K, Strickland P, Ellwood J, Larsson JN, Chooi C, Burgoyne LL, Middleton P. Effects of sevoflurane versus other general anaesthesia on emergence agitation in children. Cochrane Database Syst Rev. 2014 Sep 12;(9):CD007084. doi: 10.1002/14651858.CD007084.pub2.
Results Reference
background
PubMed Identifier
24727829
Citation
Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative alpha(2)-adrenergic agonists on postoperative behaviour in children. Br J Anaesth. 2014 Jun;112(6):982-90. doi: 10.1093/bja/aeu093. Epub 2014 Apr 11.
Results Reference
background
PubMed Identifier
29752853
Citation
Tsiotou AG, Malisiova A, Kouptsova E, Mavri M, Anagnostopoulou M, Kalliardou E. Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy with propofol anesthesia: A double-blind, randomized study. Paediatr Anaesth. 2018 Jul;28(7):632-638. doi: 10.1111/pan.13397. Epub 2018 May 12.
Results Reference
background
PubMed Identifier
18372935
Citation
Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
Results Reference
background
PubMed Identifier
24588393
Citation
Sun L, Guo R, Sun L. Dexmedetomidine for preventing sevoflurane-related emergence agitation in children: a meta-analysis of randomized controlled trials. Acta Anaesthesiol Scand. 2014 Jul;58(6):642-50. doi: 10.1111/aas.12292. Epub 2014 Mar 3.
Results Reference
background
PubMed Identifier
15562048
Citation
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
Results Reference
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Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children
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