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

NCT03596775 | Unknown Early Phase 1 DMC

• 1 other identifier: XYFY-2018-0061
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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.

  within 30 minutes after extubation in the post-anaesthesia care unit

Secondary Outcomes (4)

• Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale

  within 30 minutes after extubation in the post-anaesthesia care unit

• Rescue analgesia and sedative drug consumption

  within 30 minutes after extubation in the post-anaesthesia care unit

• Incidence of adverse events

  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

  1 day, 2 days,30 days post surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Control Comparator group

PLACEBO COMPARATOR

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

Drug: saline

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine group

saline DRUG

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

Control Comparator group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (6)

• 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;2014(9):CD007084. doi: 10.1002/14651858.CD007084.pub2.

  PMID: 25212274 BACKGROUND

• 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.

  PMID: 24727829 BACKGROUND

• 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.

  PMID: 29752853 BACKGROUND

• 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.

  PMID: 18372935 BACKGROUND

• 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.

  PMID: 24588393 BACKGROUND

• 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.

  PMID: 15562048 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jin Dong Liu, M.S

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136; liujindong1818@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 24, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)