Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Overview
- Phase
- Phase 4
- Intervention
- Dexmedetomidine
- Conditions
- Inhalational Anesthetics Adverse Reaction
- Sponsor
- Yao Yusheng
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Emergence agitation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Yao Yusheng
Dr.
Fujian Provincial Hospital
Eligibility Criteria
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.
Arms & Interventions
Dexmedetomidine group
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Intervention: Dexmedetomidine
Midazolam group
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Intervention: Midazolam
Placebo Group
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Intervention: Saline
Outcomes
Primary Outcomes
Emergence agitation
Time Frame: 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 Outcomes
- Postoperative vomiting(up to 24 hours)