Clinical trial NCT01895023: Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
Official title: Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inhalational Anesthetics Adverse Reaction
Delirium on Emergence
Strabismus Following Ocular Surgery
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2013-07-10
Enrollment: 156
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Emergence agitation
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 1 hour
Secondary outcomes:
measure: Postoperative vomiting
timeFrame: up to 24 hours
Other outcomes:
measure: Children's pain
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 1 hour
measure: Time of emergence
timeFrame: up to 1 hour
measure: Duration of PACU stay
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 1 hour
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Yusheng Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.