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

September 5, 2018 updated by: Jin Dong Liu, Xuzhou Medical University

Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.
Placebo Comparator: Control Comparator group
the children received 10ml saline over 10 minutes after induction of anesthesia
Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame: 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.
within 30 minutes after extubation in the post-anaesthesia care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time Frame: 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.
within 30 minutes after extubation in the post-anaesthesia care unit
Rescue analgesia and sedative drug consumption
Time Frame: within 30 minutes after extubation in the post-anaesthesia care unit
Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit
within 30 minutes after extubation in the post-anaesthesia care unit
Incidence of adverse events
Time Frame: within 30 minutes after extubation in the post-anaesthesia care unit
Incidence of adverse events in the post-anaesthesia care unit
within 30 minutes after extubation in the post-anaesthesia care unit
Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale
Time Frame: 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.
1 day, 2 days,30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jin Dong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data(IPD) will be available when this trial is finished and the article have been published

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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