Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
- Conditions
- Inhalational Anesthetics Adverse ReactionDelirium on EmergenceStrabismus Following Ocular Surgery
- Interventions
- Registration Number
- NCT01895023
- Lead Sponsor
- Yao Yusheng
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia
- mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Saline The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia Dexmedetomidine group Dexmedetomidine The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia Midazolam group Midazolam The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China