Delirium on Emergence Clinical Trial
Official title:
Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Verified date | January 2015 |
Source | Fujian Provincial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 6 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Fujian Provincial Hospital | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Yao Yusheng | West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Children's pain | 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. | participants will be followed for the duration of PACU stay, an expected average of 1 hour | No |
Other | Time of emergence | the time to the first response to a simple verbal command | up to 1 hour | No |
Other | Duration of PACU stay | The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort. | participants will be followed for the duration of PACU stay, an expected average of 1 hour | No |
Primary | Emergence agitation | 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. |
participants will be followed for the duration of PACU stay, an expected average of 1 hour | Yes |
Secondary | Postoperative vomiting | Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more | up to 24 hours | Yes |
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