NCT01895023

Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Yao Yusheng · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inhalational Anesthetics Adverse Reaction
• Delirium on Emergence
• Strabismus Following Ocular Surgery

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
DRUG	Midazolam	The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
DRUG	Saline	The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-07-10
• Last updated: 2015-01-06

Locations

1 site across 1 country: China