Delirium on Emergence, Inhalational Anesthetics Adverse Reaction, Strabismus Following Ocular Surgery
Conditions
Brief summary
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families. Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.
Detailed description
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores \< 10 were interpreted as an absence of agitation, scores\>= 10 were regarded as presence of agitation.
Interventions
DRUGDexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
DRUGMidazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
DRUGSaline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Sponsors
West China Hospital
Yao Yusheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia
Exclusion criteria
* mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation | participants will be followed for the duration of PACU stay, an expected average of 1 hour | Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores\>= 10 were regarded as presence of agitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative vomiting | up to 24 hours | Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more |
Other
| Measure | Time frame | Description |
|---|---|---|
| Children's pain | participants will be followed for the duration of PACU stay, an expected average of 1 hour | A Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) was used to measure five categories of pain related behaviour, each scored from 0, 1 or 2, for a maximum score of 10. |
| Time of emergence | up to 1 hour | the time to the first response to a simple verbal command |
| Duration of PACU stay | participants will be followed for the duration of PACU stay, an expected average of 1 hour | The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort. |
Countries
China
Outcome results
None listed