Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children

Early Phase 1

• Conditions: Emergence Agitation
• Interventions: Drug: Dexmedetomidine; Drug: saline

• Registration Number: NCT03596775
• Lead Sponsor: Xuzhou Medical University

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.

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Status Verified: 2018-09
• Study Start: 2018-09-01
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Age between 2-7 years old
2. American Society of Anesthesiologists（ASA） score of I or II
3. Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane

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Exclusion Criteria

1. Emergency surgery
2. were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
3. had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
4. intellectual disability, or neurological illness with agitation-like symptoms
5. weighed more than 50 kg
6. were allergic to dexmedetomidine
7. The use of sedative or analgesic medications before surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
Control Comparator group	saline	the children received 10ml saline over 10 minutes after induction of anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale	within 30 minutes after extubation in the post-anaesthesia care unit	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

Name	Time	Method
Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale	within 30 minutes after extubation in the post-anaesthesia care unit	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	within 30 minutes after extubation in the post-anaesthesia care unit	Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit
Incidence of adverse events	within 30 minutes after extubation in the post-anaesthesia care unit	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	1 day, 2 days,30 days post surgery	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.

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China