Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children
Overview
- Phase
- Early Phase 1
- Sponsor
- Xuzhou Medical University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexmedetomidine group
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
Intervention: Dexmedetomidine (Drug)
Control Comparator group
the children received 10ml saline over 10 minutes after induction of anesthesia
Intervention: saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Jin Dong Liu
Principal Investigator
Xuzhou Medical University