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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine group

the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.

Control Comparator group

the children received 10ml saline over 10 minutes after induction of anesthesia

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.

Interventions

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Dexmedetomidine

Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.

Intervention Type DRUG

saline

Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No