Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
NCT ID: NCT01895023
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2013-09-30
2014-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexmedetomidine group
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Dexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Midazolam group
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Midazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Placebo Group
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Saline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Interventions
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Dexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Midazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Saline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
6 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Yao Yusheng
OTHER
Responsible Party
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Yao Yusheng
Dr.
Principal Investigators
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Yusheng Yao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fujian Provincial Hospital
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Countries
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References
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Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.
Other Identifiers
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FujianPH-TRC-130615
Identifier Type: -
Identifier Source: org_study_id
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